Consultants
of the Biologics Consulting Group, Inc. attend several conferences
every year during which they are available to provide company information
or consulting expertise. BCG consultants often participate in continuing
educational conferences and product/service focused seminars. Below
are some conferences that BCG consultants will be attending in the
near future, or have attended in the past. Please feel free to contact
the attending consultant either before, or during the conference
for company information or to discuss a business opportunity. Also,
please see our Presentations page to view
a copy of BCG conference presentations.
Date
of Conference |
Organization
sponsoring conference |
Conference
& Presentation Title |
BCG
Consultant(s) Attending/Speaking |
Conference
Location |
| Sep 13-15, 2010 |
PDA |
Annual Conference/Joint Task Force Meeting |
Nadine
Ritter, Ph.D.(speaker) |
Washington, DC |
| Sep 20-24, 2010 |
IBC |
IBC BioProcessing International Conference
“Global Adventitious Agent Regulations of Raw Materials Used in Biopharmaceutical Manufacturing” |
Barbara Potts, Ph.D.(speaker) |
Providence, RI |
| Sep 29-Oct 1, 2010 |
BEBPA (Biopharmaceutical Emerging Best Practices Association) |
Annual BEBPA Bioassay meeting
"Quality Practices in Bioassay Labs: R&D, GLP or GMP?” |
Nadine
Ritter, Ph.D.(speaker) |
Barcelona, Spain |
| Oct 9-12, 2010 |
AABB |
Annual Meeting & TXPO |
Joseph Fratantoni, MD |
Baltimore, MD |
| Oct 12, 2010 |
Medical Design & Manufacturing (MD&M) |
510(k) Reform: Impact on preclinical testing requirements |
Miriam Provost, PhD (speaker) |
Minneapolis, MN |
| Oct 14-15, 2010 |
Informa PTI-UK |
Training Class: CMC Analytical, Comparability and Stability Studies for Biotechnology Products |
Nadine
Ritter, Ph.D.(instructor) |
London, UK |
| Oct 19-20, 2010 |
International Pharmaceutical Academy (IPA) |
Advances and Efficiencies in Stability Testing for the Pharmaceutical & BioTech Industry
Advances and Efficiencies in Stability Testing for the Pharmaceutical & BioTech Industry
and Efficiencies in Stability Testing for the Pharmaceutical & BioTech Industry
|
Nanda
Subbarao, Ph.D.
(speaker) |
Montreal, Canada |
| Oct 20-22, 2010 |
IBC |
Well Characterized Biopharmaceuticals: 14th Annual Meeting |
Nadine
Ritter, Ph.D.(speaker) |
Bethesda, MD |
| Oct 24-27 2010 |
RAPS |
Annual Conference and Exhibition |
Andra
Miller, Ph.D.
Blair Fraser, Ph.D.
Barbara Potts, Ph.D.
Darin
Weber, Ph.D.
Stephen Rhodes, M.S.
(speakers)
|
San Jose, CA |
| Oct 25-27, 2010 |
PDA |
PDA’s 5th Annual Global Conference on Pharmaceutical Microbiology
“The Myths of Virology and Mycoplasmology”
PDA Mycoplasma Filtration class |
Barbara Potts, Ph.D.(speaker) |
Washington, DC |
| Oct 27-29, 2010 |
|
World Drug Discovery and Development Summit 2010 |
Orest Hurko M.D.(speaker) |
Copenhagen, Denmark |
Oct 27-28 2010 |
Informa Life Sciences |
BioProduction 2010 |
Nanda
Subbarao, Ph.D.
(speaker) |
Barcelona, Spain |
| Nov 7-8, 2010 |
American College of Toxicology (ACT) |
31st Annual Meeting |
John
Jessop, Ph.D., MPH |
Baltimore, MD |
| Nov 8-9, 2010 |
CaSSS |
2nd Annual Bioassays 2010: Scientific Approaches and Regulatory Strategies |
Nadine
Ritter, Ph.D.(speaker) |
Bethesda, MD |
| Nov 14-18, 2010 |
AAPS |
Annual Meeting |
Nadine
Ritter, Ph.D. |
New Orleans, LA |
| Nov 15-17, 2010 |
Informa Life Sciences |
Regulatory Affairs for Biopharmaceuticals
Workshop: "CMC Regulatory Compliance for Biopharmaceuticals" |
Nadine
Ritter, Ph.D.(speaker) |
Berlin Germany |
Nov 16-19, 2010 |
Informa Life Sciences |
11th Annual EuroTIDES 2010
"Peptides and Stability Testing Requirements" |
David
Lin, Ph.D.
(speaker) |
Barcelona, Spain |
| Dec 4-7, 2010 |
American Society of Hematology |
Annual Meeting |
Joseph Fratantoni, MD |
Orlando, FL |
Dec 7-9, 2010 |
CBI |
Stability Programs Forum
“Stability Testing for Biotechnology/Biologic Products” |
David
Lin, Ph.D.
(speaker) |
Philadelphia, PA |
| Mar 6-10, 2011 |
Society of Toxicology (SOT) |
Annual Meeting & ToxExpo |
John
Jessop, Ph.D., MPH |
Washington, DC |
Past
Conferences Attended... |
| Aug 1-6, 2010 |
ACS |
Recovery of Biological Products XIV
Session: QbD in practice – Reconciling regulators expectations and industry implementation |
Nadine
Ritter, Ph.D.(speaker) |
Lake Tahoe |
| July 28-30, 2010 |
IVT |
7th Annual Method Validation
“Ensure Method Validation Compliance through a Review of FDA Warning Letters”
“Setting Biological Product Specifications” |
David
Lin, Ph.D.
(speaker) |
San Francisco, CA |
| Jul 19-20, 2010 |
CaSSS |
CMC Strategy Forum-US: QbD for Biologics: Learning’s from the Product Development and Realization Case Study and the FDA Pilot Program |
Nadine
Ritter, Ph.D.(speaker) |
Bethesda, MD |
| Jun 16-19, 2010 |
International Society for Stem Cell Research |
International Society for Stem Cell Research 8th Annual Meeting |
Barbara Potts, PhD |
San Francisco, CA |
| June 15, 2010 |
International Society for Stem Cell Research |
ISSCR/CIRM/ISCT Regulatory Workshop: Stem Cell Therapies in Clinical Trials – Best Practices and the Need for Harmonization |
Darin
Weber, Ph.D. (speaker) |
San Francisco, CA |
| Jun 14-15, 2010 |
USP |
Bioassay Workshop |
Nadine
Ritter, Ph.D. |
Rockville, MD |
| June 3-10, 2010 |
Cord Blood Forum |
International Cord Blood Transplantation Symposium |
Ellen
M. Areman, MS, SBB |
San Francisco, CA |
| June 5, 2010 |
Chinese American Biopharmaceutical Society |
Regulatory and QA Considerations for Drug Product Development |
Louise Johnson |
Foster City, CA |
| May 26, 2010 |
BenAstrum |
Preparing for FDA GLP Audits |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| May 25, 2010 |
BenAstrum |
Analytical CMC Studies for Biotechnology Products: ICH CTD Requirements |
Nadine
Ritter, Ph.D.(instructor) |
Webinar |
| May 17-19, 2010 |
PDA |
Vaccines conference |
Jim Kenimer, Ph.D. (moderator)
Peter Patriarca (presenter)
Ann Sutton |
Bethesda, MD |
| May 16-19, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
National Biotechnology Conference
Hot Topic Session: Risk-Based Product Development CMC Strategies: Pay Me Now or Pay Me Later! |
Nadine
Ritter, Ph.D.(speaker) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: Stability of Novel Biological Products |
Nanda
Subbarao, Ph.D.
(moderator) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: ‘You are manufacturing protein from – What?! Novel expression systems.’ |
Nanda
Subbarao, Ph.D.
(moderator) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: The Heparin Contamination Incident-what We Have Learnt from it |
Nanda
Subbarao, Ph.D.
(moderator) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: Extractables and Leachables in Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
San Francisco, CA |
| Apr 29, 2010 |
Compliance Online |
Testing for Particulates in Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 10:00am PST |
| Apr 28, 2010 |
BenAstrum |
An FDA Perspective on Analytical Method Validation |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| Apr 26-28, 2010 |
CaSSS |
EU CMC Strategy Forum: Challenges Facing Biopharmaceutical Development in the Next Decade |
Nadine
Ritter, Ph.D.(speaker) |
Vienna, Austria |
| Apr 22, 2010 |
PDA Mycoplasma Task Force Filtration sub group |
Consensus rating for evaluating filters for the removal of mycoplasma. |
Barbara Potts, PhD
(training co-leader) |
Frankfurt, Germany |
| Apr 20-21, 2010 |
PDA |
2010 PDA Workshop on the Impact of Bio-Films on Pharmaceutical and Biopharmaceutical Manufacturing |
Barbara Potts, PhD
(co-chair) |
Frankfurt, Germany |
| Apr 20, 2010 |
BenAstrum |
Selection and Validation of Test Methods for Host Cell Proteins |
Nadine
Ritter, Ph.D.(instructor) |
Webinar |
| Apr 13-14, 2010 |
Informa Life Sciences |
Forced Degradation for Biologics |
Nadine
Ritter, Ph.D. |
Danubius Regent’s Park Hotel
London, UK |
| Apr 9, 2010 |
BenAstrum |
Annual GLP Training |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 8:45 am -11 am, EST |
| Apr 8, 2010 |
Compliance Online |
Why we need an effective Equipment Program? Implement USP <1058> |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 10:00am PST |
| Apr 7, 2010 |
BayBio |
BAYBIO2010 Life Sciences Innovation: Drivers and Barriers |
Barbara Potts, PhD |
Burlingame, CA |
| Mar 30, 2010 |
BenAstrum |
Recent Developments in the WHO Vaccine Stability Guidance – Key Definitions |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar 1:15 pm- 3.30 EST |
| Mar 25-26, 2010 |
Informa PTI-UK |
Training Class: CMC Analytical, Comparability and Stability Studies for Biotechnology Products |
Nadine
Ritter, Ph.D.(instructor) |
Regus St James's Park, London, UK |
| Mar 24, 2010 |
BenAstrum |
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| Mar 22, 2010 |
Compliance Online |
How to comply with recent expectations for extractables /Leachables testing for Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 10:00am PST |
| March 17, 2010 |
BenAstrum |
Preparing for FDA GLP Audits |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| March 15, 2010 |
BenAstrum |
Comprehensive Forced Degradation Studies to Validate Stability–Indicating Methods for Biotechnology Products |
Nadine
Ritter, Ph.D.(instructor) |
Webinar |
| Mar 15-19, 2010 |
PDA |
2010 PDA Annual Meeting
"Update on the Activities of the Mycoplasma Task Force" |
Barbara Potts, PhD
(speaker) |
Orlando, FL |
| Mar 8 - 10, 2010 |
AABB/FDA |
Cord Blood Licensure: A Workshop |
Ellen
M. Areman, MS, SBB(speaker/moderator) |
Rockville, MD |
| March 9 - 10, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference Programming Committee 2011 Jamboree |
Nanda
Subbarao, Ph.D.
(regulatory sciences section leader ) |
Chicago, IL |
| Feb 3-5, 2010 |
Pharma Conference |
6th Annual FDA and the Changing Paradigm for HCT/P Regulation
"Labeling for HCT/Ps – Convergence or Divergence?" |
Darin
Weber, Ph.D. (speaker) |
Orlando, FL |
| Feb 2-5, 2010 |
DIA |
Generating and Weighing Evidence in Drug Development and Regulatory Decision Making
"Development of an IVD with Approved Drugs" |
Ron Salerno, PhD
session chair |
Bethesda, MD |
| Jan. 25-27, 2010 |
Phacilitate |
Vaccine Forum Washington 2010 |
Michael L. Salgaller, PhD |
Washington, DC |
| Jan. 24-27, 2010 |
CaSSS |
CMC Strategy Forum/WCBP Industry-FDA meeting |
Nadine
Ritter, Ph.D.(speaker) |
Washington, DC |
| Jan. 12-13, 2010 |
EBD Group/Demy-Colton |
Biotech Showcase 2010 |
Michael L. Salgaller, PhD
Ron Marchesani |
San Francisco, CA |
| Jan. 12-13, 2010 |
CHI Peptalk |
Enabling Analytical Methods for Extractables and Leachables Testing for Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
San Diego, CA |
| Jan. 12-13, 2010 |
CHI Peptalk |
Characterization and Analysis of Particulates: Methods and Tools |
Nanda
Subbarao, Ph.D.
(speaker) |
San Diego, CA |
| Dec. 5-8, 2009 |
American Society of Hematology |
51st ASH Annual Meeting and Exposition |
Joseph Fratantoni, MD
John Humphries, MD |
New Orleans, LA |
| Dec. 3-4, 2009 |
FasterCures |
Partnering for Cures |
Michael L. Salgaller, PhD |
New York, NY |
| Nov. 12-13, 2009 |
IBC Life Sciences |
De-Risking Next Generation Biologics
De-Risking Next Generation Biologics
Risking Next Generation Biologics
|
Blair Fraser, Ph.D.
(speaker) |
Bethesda, MD |
| Nov. 12, 2009 |
BenAstrum |
Clinical Product Development: From Pre-IND to BLA/NDA |
Julia Barrett, MD
(course instructor) |
Webinar (1:20-3:15 EST) |
| Nov. 11-12, 2009 |
IBC Life Sciences |
GLPs and GMPs for Biopharmaceutical Development |
Nanda
Subbarao, Ph.D.
(course instructor) |
San Francisco, CA |
| Nov. 10, 2009 |
BioWest |
Annual Meeting (Booth #34) |
Julia Barrett, MD
Calley Herzog
Michael Salgaller, Ph.D.
Ann Sutton
Annie Zurbay |
Denver, CO |
| Nov. 9-11, 2009 |
IBC Life Sciences |
Well Characterized Biologicals |
Nadine
Ritter, Ph.D.(chairperson) |
Bethesda, MD |
| Nov. 9-10, 2009 |
IBC Life Sciences |
Forced Degradation studies for Biopharmaceuticals |
Nanda
Subbarao, Ph.D.
(course instructor) |
San Francisco, CA |
| Nov. 4-6, 2009 |
BioFlorida |
12th Annual Conference |
Michael Salgaller, Ph.D.
Holly Scott |
Orlando, FL |
| Nov. 4-6, 2009 |
Mid-Atlantic BIO |
2009 Mid-Atlantic Bio |
Jim Kenimer, Ph.D. |
Washington, DC |
| Nov. 1-4, 2009 |
American College of Toxicology (ACT) |
30th Annual Meeting |
Melanie Hartsough, PhD
John
Jessop, Ph.D., MPH |
Palm Springs, CA |
| Oct. 28-31, 2009 |
iSBTc (International Society for the Biological Therapy of Cancer) |
2009 Annual Meeting |
Michael Salgaller, Ph.D. |
Washington, DC |
| Oct. 26-29, 2009 |
Seton Hall Law School |
Health Care Compliance Certification Program
"Advertising & Promotion of Medical Devices" |
Stuart Portnoy, MD (speaker) |
New Brunswick, NJ |
| Oct. 26, 2009 |
|
FDA Immunotoxicology Forum |
Melanie Hartsough, PhD
John
Jessop, Ph.D., MPH |
Silver Spring, MD |
| Oct. 24-27, 2009 |
AABB (American Association of Blood Banks) |
Annual Meeting & TXPO
Validation Rules & Regs: How do they apply to me?
|
Joseph Fratantoni, MD
Ellen
M. Areman, MS, SBB
(moderator) |
New Orleans, LA |
| Oct. 7-10, 2009 |
Biomedical Engineering Society (BMES) |
BMES 2009 Annual Fall Scientific Meeting
"Translational Bioengineering: Overcoming the Ultimate Barrier to
Entry: Commercialization, Regulation, and the FDA" |
Ian Millett, Ph.D.
(speaker) |
Pittsburgh, PA |
| Oct. 7, 2009 |
Colorado State University BioMARC (Biopharmaceutical Manufacturing & Academic Resource Center) |
Navigating Clinical Trials |
Julia Barrett, MD
(course instructor) |
Loveland, CO |
| Oct. 1-2, 2009 |
IBC Life Sciences |
GLPs and GMPs for Biopharmaceutical Development |
Nanda
Subbarao, Ph.D.
(course instructor) |
Boston, MA |
| Sept. 30 - Oct. 2, 2009 |
Roche Colorado |
Roche Colorado Corporation Peptide Symposium |
Blair Fraser, Ph.D.
(speaker) |
Boulder, CO |
| Sept. 29-30, 2009 |
IBC Life Sciences |
Forced Degradation studies for Biopharmaceuticals |
Nanda
Subbarao, Ph.D.
(course instructor) |
Boston, MA |
| Sept. 28, 2009 |
DIA |
Biosimilar Workshop |
John
Jessop, Ph.D., MPH |
London, UK |
| Sept. 24-25, 2009 |
AAPS (American Association of Pharmaceutical Scientists) |
Current Trends in Stability
"Stability requirements for Biologics" |
Nanda
Subbarao, Ph.D.
(speaker/moderator) |
National Harbor, MD |
| Sept. 21-23, 2009 |
Genetics Policy Institute |
World Stem Cell Summit |
Ellen
M. Areman, MS, SBB
|
Baltimore, MD |
| Sept. 16-17, 2009 |
PDA |
PDA Combination Products Workshop
"Status of Current Regulatory Frameworks and Perceived Problems" (Gross)
"Plenary Session 6 - Safety Reporting" (Portnoy) |
Michael Gross, Ph.D. (speaker)
Stuart Portnoy, MD (speaker) |
Washington, DC |
| Sept. 13-16, 2009 |
RAPS |
Annual Conference - Booth #520
"Implementation of the Case-by-Case Approach: Practical Applications" (Hartsough)
"Combination Products & Cross Labeling -- Fact or Fiction?" (Portnoy)
"Navigating the Scientific and Regulatory Dividing Line Between Drugs and Devices" (Provost)
"Tissue Engineered Combination Products— Coordination Is Key" (Provost) |
Melanie Hartsough, PhD (speaker)
Calley Herzog
Ian Millett, PhD
Stuart Portnoy, MD (speaker)
Miriam Provost, PhD
(speaker/chairperson)
Michael
Trapani, MS, MBA
Kelly Reich, MS
Holli Vaughan, MS, RAC |
Philadelphia, PA |
| Sept. 12-13, 2009 |
SEAK, Inc. |
National Non-Clinical Careers For Physicians
"Networking Your Way Into a Non-Clinical Career:
Industry, Government & Consulting" |
Stuart
Portnoy, MD
(speaker) |
Chicago, IL |
| Sept. 9, 2009 |
BenAstrum |
USP – Chapter 467 & GMP Requirements for Testing Residual Solvents |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar
1:00-4:00pm EDT |
| Sept. 8-9, 2009 |
IIR |
Stability Testing for Biologics
"Stability Testing Performed Over A Product Lifecycle" |
David
Lin, Ph.D.
(speaker) |
Prague, Czech Republic |
| Aug. 19-21, 2009 |
IVT (Institute of Validation Technology) |
8th Annual Laboratory Compliance Week
"Develop Effective Stability Testing of New Drug Substances and Products" (Lin)
Handling OOS/OOT Results and Failure Investigations Workshop (Subbarao) |
David
Lin, Ph.D.
(speaker)
Nanda
Subbarao, Ph.D.
(speaker) |
Philadelphia, PA |
| Aug. 17-18, 2009 |
Cambridge Healthtech Institute |
Production & Manufacturing of Vaccines (part of the ImVacs Immunotherapeutics & Vaccine Summit)
"Essential Quality Considerations for Today’s Manufacturing of Vaccines: The Do’s and Don’ts for Successful Audits and Inspections" |
Ron Marchesani
(speaker) |
Providence, RI |
| July 29-30, 2009 |
PDA |
PDA Cell Substrate Workshop |
T.W. Tanaka (speaker) |
Bethesda, MD |
| July 16, 2009 |
BenAstrum |
Comprehensive Forced Degradation Studies to Validate Stability–Indicating Methods for Biotechnology Products |
Nadine
Ritter, Ph.D.(speaker) |
Webinar
1:20-3:45pm EDT |
| July 16, 2009 |
PACT (Production Assistance for Cellular Therapies) / NHLBI |
Deviation Management of Type 351 & 361 Cell Products |
Ellen
M. Areman, MS, SBB
(speaker)
|
Webinar
12:00 EDT |
| July 16, 2009 |
Compliance Online |
The Pre-IND Process: Changes in Working with the FDA and Regulatory Procedures. |
David
J. Pepperl, Ph.D. (speaker) |
Webinar
1:00-2:30 pm EDT |
| July 15, 2009 |
RAPS |
RAPS Business and Leadership Series: Outsourcing |
David
J. Pepperl, Ph.D. (speaker)
Michael
Trapani, MS, MBA
(speaker) |
Webcast 12:00–1:30 pm |
| July 13-16, 2009 |
ISTH (International Society on Thrombosis and Haemostasis) |
ISTH 2009 Congress
"Efficacy of Full-length Recombinant Human Plasmin in a Porcine Model of Arteriovenous Graft Thrombosis " |
John Humphries, MD
(speaker) |
Boston, MA |
| July 8, 2009 |
BenAstrum |
Recent Developments in the WHO/ASEAN Stability Guidance |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar 1:00–4:00 pm |
| Jun. 25-26, 2009 |
IIR-PTI |
CMC Analytical, Comparability and Stability Studies for Biotechnology Products
"Current Expectations, Practical Considerations” |
Nadine
Ritter, Ph.D.(speaker) |
London , UK |
| Jun. 22-24, 2009 |
American Association of Pharmaceutical Scientists (AAPS) |
AAPS 2009 National Biotechnology Conference
"Phase I INDs for Biologics: How Much Data is Adequate" |
Ron Marchesani
(speaker) |
Seattle, WA |
| Jun. 21-23, 2009 |
DIA |
45th DIA Annual Meeting |
Calley Herzog Louise Johnson
David
Lin, Ph.D. Michael Salgaller, Ph.D.
Annie
Zurbay, RN, MSN, ND |
San Diego, CA |
| Jun. 11, 2009 |
ACRP Northern California Chapter |
“Emerging Markets: Clinical Trials in India” |
Louise Johnson (speaker) |
South San Francisco, CA |
| Jun. 10, 2009 |
BenAstrum |
“Comprehensive Forced Degradation Studies to Validate Stability-Indicating Methods for Biotechnology Products” |
Nadine
Ritter, Ph.D.(speaker) |
webinar |
| Jun. 8-11, 2009 |
Seton Hall Law School |
Health Care Compliance Certification Program
"Advertising & Promotion of Medical Devices" |
Stuart
Portnoy, MD
(speaker) |
Newark, NJ |
| June 2, 2009 |
BenAstrum |
Regulatory Expectations for Biologics Facilities: an ex-FDA Inspector's Outlook |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| May 27-29, 2009 |
Cambridge Health Institute |
Biomarker World Congress 2009 |
Ron Salerno, PhD |
Philadelphia, PA |
| May 21-22, 2009 |
Prescription Pharma Support |
CMC Analytical, Comparability And Stability Studies For Biotechnology Products: Current Expectations, Practical Considerations
“Analytical and Stability Studies for Biotechnology Products” |
Nadine
Ritter, Ph.D.(speaker) |
Signapore |
| May 18-21, 2009 |
BIO |
BIO 2009 (booth #5232) |
Michael Salgaller, PhD
Jim Kenimer, PhD
Wilson
W. Bryan, MD
|
Atlanta, GA |
| May 18-19, 2009 |
Prescription Pharma Support |
CMC Analytical, Comparability And Stability Studies For Biotechnology Products: Current Expectations, Practical Considerations
“Analytical and Stability Studies for Biotechnology Products” |
Nadine
Ritter, Ph.D.(speaker) |
Bangalore, India |
| May 11-13, 2009 |
Pharmaceutical Education and Research Institute (PERI) |
Clinical Trial Planning and Management
"Trial Design for Efficient Drug Development " |
Wilson
W. Bryan, MD
(co-director) |
Arlington, VA |
| May 6, 2009 |
UMBC Graduate Program in Biotechnology |
"Laboratory Quality Practices: R&D, GLP and GMP” |
Nadine
Ritter, Ph.D.(speaker) |
Baltimore, MD |
| May 4-6, 2009 |
Society for Clinical Trials |
Annual Meeting |
Wilson
W. Bryan, MD |
Atlanta, Georgia |
| May 3-6, 2009 |
International Society for Cellular Therapy (ISCT) |
Annual Meeting
Pre-Conference Symposium: Translation of Stem Cell Therapies Symposium
"Product Development Challenges for Stem Cell Therapies"
"Quality and Manufacturing Considerations - From Concept to Pre-BLA"
Session: Balancing Regulatory Expectations and Industry Realities in Proof of Concept Studies and Preclinical Data
"Nonclinical Development of Cell Therapy Products – Reconciling FDA Expectations with Industry Realities" |
Darin
Weber, Ph.D. (speaker)
David
J. Pepperl, Ph.D. (speaker) |
San Diego, CA |
| Apr. 26 - May 1, 2009 |
American Academy of Neurology |
Annual Meeting |
Wilson
W. Bryan, MD
|
Seattle, WA |
| Apr. 25-29, 2009 |
CMC Strategy Forum Europe 2009 |
"CMC Perspectives on Biological Investigational Medicinal Products in Clinical Trials” |
Nadine
Ritter, Ph.D.(speaker)
Ruth Wolff, Ph.D. (speaker) |
Lisbon, Portugal |
| Apr. 16, 2009 |
BenAstrum |
Selection and Validation of Test Methods for Host Cell Proteins |
Nadine
Ritter, Ph.D.(speaker) |
webinar |
| Apr. 15, 2009 |
University of California, British Consulate-General, Canadian Consulate |
Stem Cell Research and Regenerative Medicine
The Promise of Stem Cell Research to Enable Regenerative Medicine |
Darin
Weber, Ph.D. |
San Francisco, CA |
| Apr. 9, 2009 |
North Carolina Biotechnology Center |
Combination Products Meeting |
Angela
Blackwell, MS
(panelist) |
Research Triangle Park, NC |
| Apr. 2, 2009 |
Regulatory Affairs Professional Society (RAPS) |
2009 RAPS Horizons Conference & Exhibition
"The Challenges of Nanotechnology:
Navigating the Field and the Regulatory Pathways" |
Stuart
Portnoy, MD
(speaker) |
San Francisco, CA |
| Mar. 31, 2009 |
Compliance Online |
Preparing for FDA Inspections |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| Mar. 12, 2009 |
Compliance Online |
Facility Design Considerations |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| Mar. 11, 2009 |
BenAstrum |
Preparing for FDA Inspections of Biologics and Biotech Facilities |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:20 PM EST |
| Mar. 9, 2009 |
Compliance Online |
Preparing for FDA Inspections of Devices and Combination Products |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| Mar. 5-6, 2009 |
International Pharmaceutical Academy |
FDA Pre-Approval Inspections |
Nanda
Subbarao, Ph.D.
(speaker) |
Somerset, NJ |
| Mar. 2-3, 2009 |
World Research Group |
Cell Based Assays in Drug Development: Hands on Instruction on How to Stay Ahead of the Curve & Maximize Assay Quality while Minimizing Costs |
Nadine
Ritter, Ph.D.(speaker) |
Washington, DC |
| Mar. 2-3, 2009 |
IBC Life Sciences |
Process Validation for Biopharmaceuticals |
Ron Marchesani |
Carlsbad, CA |
| Feb. 25, 2009 |
BenAstrum |
Preparing for FDA Inspections of Biologics and Biotech Facilities |
John
R. Godshalk, MSE, MBA
(speaker) |
webinar |
| Feb. 18-20, 2009 |
Texas Scottish Rite Hospital for Children |
Carrell-Krusen Neuromuscular Symposium |
Wilson
W. Bryan, MD |
Dallas, Texas |
| Feb. 9-12, 2009 |
University of Texas |
International Conference on Drug Development
"Biomarker and Adverse Event Consortia Updates and Post Marketing Commitments" |
Ron Salerno, PhD
(moderator) |
Austin, TX |
| Feb. 3-4, 2009 |
DIA |
Regulatory and Scientific Issues that Challenge Comparability Assessment of Biopharmaceuticals |
John
Jessop, Ph.D., MPH |
Arlington, VA |
| Jan. 29, 2009 |
ComplianceOnline.com |
Webinar
"Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices" |
Stuart
Portnoy, MD
(speaker) |
webinar |
| Jan. 28, 2009 |
Vanderbilt University |
"The FDA Approval Process for Medical Devices" |
Angela
Blackwell, MS
(speaker) |
Nashville, TN |
| Jan. 26-27, 2009 |
Phacilitate |
Cell and Gene Therapy Forum 2009
"Designing cell and gene therapy clinical trials" |
Andra
Miller, Ph.D.
(session chair) |
Washington, DC |
| Jan. 19-20, 2009 |
BIO |
BIO Asia Partnering Conference 2009 |
T.W. Tanaka |
Tokyo, Japan |
| Jan. 12-14, 2009 |
CASSS |
WCBP 2009 |
Ron Marchesani |
San Francisco, CA |
| Dec. 10, 2008 |
Colorado State University |
Regional Training Center for Product Translation
“From PIND to Licensure” |
Julia
Barrett, M.D., MPH
(speaker) |
Fort Collins, CO |
| Dec. 8-9, 2008 |
IBC Life Sciences |
Biopharmaceuticals Manufacturing and Development Summit |
Lourdes Bermejo, MS |
Durham, NC |
| Nov. 26, 2008 |
BenAstrum |
"Preparing for FDA Inspections of Biologics and Biotech Facilities" |
John
R. Godshalk, MSE, MBA
(speaker) |
Webinar |
| Nov. 25-26, 2008 |
Informa Life Sciences |
17th annual Medical
Device
Regulations
“An Introduction to FDA Regulations for Medical Devices”. |
Miriam Provost, PhD |
Amsterdam, The Netherlands |
| Nov. 20, 2008 |
National Academy of Sciences |
Translation of Stem Cells into Clinical Stem Cell Therapeutics
Public Symposium |
Darin
Weber, Ph.D.
(speaker) |
Washington, DC |
| Nov.
18-21, 2008 |
ASTM |
November
Meeting week Division IV Tissue Engineered Medical Products |
Angela
Blackwell, MS |
Miami
Beach, FL |
| Nov. 17-18, 2008 |
IBC |
6th Annual Global Follow-On Biologics |
Jim Kenimer, PhD |
Bethesda, MD |
| Nov. 10-12, 2008 |
IBC |
12th Annual Well-Characterized Biologicals
"Overview of CMC Strategy Forum on Glycosylation of Biotechnology Products" |
Nadine
Ritter, Ph.D.(speaker) |
Reston, VA |
| Nov. 10-11, 2008 |
American College of Toxicology |
From Bench to Bedside: The absolute Essentials of Vaccine Development (course)
Adjuvants in Vaccine Development: Regulatory Considerations (session) |
Steve Kunder, Ph.D. (speaker) |
Tucson, AZ |
| Nov 10-11, 2008 |
PDA (Parenteral Drug Association) |
Development and Regulation of Clinical Trial supplies |
Eugene
Johnston, CQE, CQA (speaker) |
Boston, MA |
| Nov
9-12, 2008 |
ACT
(American College of Toxicology) |
29th
Annual Meeting
Introduction of Biologics (Hartsough) |
John
Jessop, Ph.D., MPH
Melanie Hartsough, Ph.D. (speaker)
David
J. Pepperl, Ph.D. |
Tuscon, AZ |
| Nov. 5, 2008 |
UMBC Biotech Forum 2008 |
From Bench to Business: Biotech Career Opportunities |
Nadine
Ritter, Ph.D.(speaker) |
Baltimore, MD |
| Nov. 4, 2008 |
BenAstrum |
“Quality Management Systems: Key Elements & Regulatory Expectations” |
Eugene
Johnston, CQE, CQA (speaker) |
Webinar |
| Oct. 28, 2008 |
BenAstrum |
Regulatory Expectations for Biologics Facilities: an ex-FDA Inspector's Outlook"
|
John
R. Godshalk, MSE, MBA
(speaker) |
Webinar |
| Oct 22-23, 2008 |
IIR |
Stability Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.(speaker)
|
London, UK |
| Oct. 15-17, 2008 |
Bio-Japan |
Bio-Japan |
Jim Kenimer, PhD T.W. Tanaka
Shin-ichi Kamachi, PhD
Masamichi Gotoh |
Yokohama, Japan |
| Oct. 14, 2008 |
BenAstrum |
“Recent Developments in the WHO/ASEAN Stability Guidance”
|
Nanda
Subbaro, Ph.D.
(speaker) |
Webinar |
| Oct 12-17, 2008 |
Transcatheter Cardiovascular Therapeutics |
TCT 2008 |
Susan Bowley, PhD |
Washington, DC |
| Oct 9-10, 2008 |
International Pharmaceutical Academy |
Effective Response to Process Deviations and Failures
"Conducting Failure Investigations" |
Eugene
Johnston, CQE, CQA (speaker) |
Toronto, Canada |
| Oct
4-7, 2008 |
AABB
(American Association of Blood Banks) |
Annual
Meeting and TXPO
"Benchside to Bedside: Translation of CT Products into Clinic" - Weber
|
Ellen
M. Areman, MS, SBB
(session
chair)
Darin
Weber, Ph.D.
(speaker
|
Montreal,
Canada |
| Sept. 30, 2008 |
Benastrum |
The Significance of Quality Systems |
Eugene
Johnston, CQE, CQA (speaker) |
Webinar |
| Sept
28-Oct 4, 2008 |
|
ISO
TC 106 Dental Devices Annual Meeting |
Angela
Blackwell, MS |
Göteborg,
Sweden |
| Sept. 28-Oct. 1, 2008 |
Cambridge Healthtech Institute |
Biomarker
Discovery
Summit 2008
|
Ron Salerno, PhD |
Philadelphia, PA |
| Sept. 24, 2008 |
Georgia Bio |
2008 Georgia Life Sciences Summit |
Eugene
Johnston, CQE, CQA
Jim Kenimer, PhD |
Atlanta, GA |
| Sept. 22-24, 2008 |
International Society for Cell Therapy (ISCT) |
8th Annual Somatic Cell Therapy Symposium
"IND Overview"
"Problems in Product Development for Cell-Based Therapies"
Panelist for "Product Nomenclature" Session
|
Darin
Weber, Ph.D.
(speaker) |
Bethesda, MD |
| Sept.
14-17, 2008 |
Regulatory
Affairs Professional Society (RAPS) |
Annual
Conference & Exhibition
"Follow-on
Biologics, (Biosimilars)” (Subbarao)
|
Speakers
Nanda
Subbaro, Ph.D.
Lorianne Baranauskas
John Jessop, PhD
Reggie
Neal
Kelly
Reich, MS
Michael
Trapani, MS, MBA
Holli
Vaughan, MS, RAC
Keith Wells, Ph.D.
|
Boston,
MA |
| Sept.
8-12, 2008 |
PDA/FDA |
2008
PDA/FDA Joint Regulatory Conference |
Nadine
Ritter, Ph.D. |
Washington,
DC |
| Aug. 21, 2008 |
BenAstrum |
"Immunogenicity Assays and the Current Regulatory Guidelines"
|
Nanda
Subbaro, Ph.D. (speaker) |
Live Web Seminar & Group Discussion |
| Aug.
14, 2008 |
Cambridge
Healthtech Institute |
Clinical
Risk Management and Safety for Vaccines |
Julia
Barrett, M.D., MPH
(speaker) |
Cambridge,
MA |
| July
24-25, 2008 |
CASSS |
CMC
Strategy Forum |
Nadine
Ritter, Ph.D. |
Bethesda,
MD |
| June 25-26, 2008 |
IIR |
Stability Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.(speaker)
|
London, UK |
| June
22-26, 2008 |
Drug
Information Association |
44th
Annual Meeting |
Annie
Zurbay, RN, MSN, ND
Ron
Salerno, Ph.D. |
Boston,
MA |
| June 19, 2008 |
ComplianceOnline |
Implementing a GCP Vendor Qualification Program: Ensuring your vendors are in compliance with FDA requirements |
Carl
Anderson
(speaker) |
online (10 am PDT) |
| June 18, 2008 |
ASME (American Society of Mechanical Engineers) |
3rd Frontiers in Biomedical Devices Conference and Exhibition |
Susan Bowley, Ph.D. |
Irvine, CA |
| June 17-20, 2008 |
BIO
(Biotechnology Industry Organization) |
BIO
2008 (Booth #1939) |
Jim Kenimer
Ron Marchesani
Ron Salerno
Gil Salud |
San Diego, CA |
| June
16-19, 2008 |
Seton
Hall Law School
|
Health
Care Compliance Certification Program
"Advertising
& Promotion of Medical Devices" |
Stuart
Portnoy, MD
(speaker) |
Newark,
NJ |
| June
12-13, 2008 |
Center
for Business Intelligence (CBI) |
3rd
Annual Stability Programs: Impurity Control, Global Compliance,
Program Design and Stability Data Management for the Bio/Pharmaceutical
Industry
“Develop
Complex Stability Programs for Biologics”
|
David
Lin, Ph.D.
(speaker) |
Philadelphia,
PA |
| June 11-12, 2008 |
Orange County Regulatory Affairs |
11th Annual FDA/OCRA Educational Conference |
Ruth Wager, Ph.D. |
Irvine, CA |
| June
8-11, 2008 |
Preclinical
Training Institute |
Study
Directing: Principles and Practices
"Your
"other boss": How an FDA reviewer reads your reports" |
Melanie
Hartsough, Ph.D.
(speaker) |
South
Lake Tahoe, CA |
| June 5-6, 2008 |
FDLI |
Introduction to Biotechnology Law
and Regulation |
John
R. Godshalk, MSE, MBA
(speaker) |
Washington, DC |
| May
19– 21, 2008 |
IBC
Life Sciences |
TIDES
2008: Oligonucleotide and Peptide Technology and Product Development
Conference Proven Strategies for Successful Drug and Diagnostic
Development
|
David
Lin, Ph.D. |
Las
Vegas, NV |
| May
18 – 21, 2008 |
Society
for Clinical Trials |
29th
Annual Meeting |
Wilson
W. Bryan, MD |
St.
Louis, MO |
| May
17-20, 2008 |
ISCT |
ISCT
14th Annual Meeting |
speakers
Ellen
M. Areman, MS, SBB
David
J. Pepperl, Ph.D.
Darin
Weber, Ph.D. |
Miami,
FL |
| May
8-10, 2008 |
UCSC
Extension in Silicon Valley |
Special
Regulatory Programs - click below to sign up for either
course presented by BCG at UCSC
"FDA
Regulation of Biotechnology and Biologics Products: From IND
to BLA"
"Medical
Devices and the FDA: An Insider's Perspective" |
Jim
Kenimer,Ph.D.
Ron
Marchesani
Janice
Wilson, Ph.D.
Carl
Anderson
Susan
Bowley, Ph.D.
Stuart
Portnoy, M.D. |
University
of California Extension, Santa Cruz |
| May
6-9, 2008 |
ASTM
International |
Committee
Week
Division
IV Tissue Engineered Medical Products
Medical
and Surgical Materials and Devices |
Angela
Blackwell, MS
Susan
M. Bowley, Ph.D.
|
Denver,
CO |
| May
6, 2008 |
FDA
& Industry Conference |
Creating
New Knowledge, FDA & Industry in dialogue |
Michael
Trapani, MS, MBA |
Philadelphia,
PA |
| April
29-May 2, 2008 |
Institute
of Validation Technology (IVT) |
Lab
Compliance
“Stability
Testing Fundamentals and Considerations in the Current Regulatory
Environment” |
David
Lin, Ph.D.
(speaker) |
Baltimore,
MD |
| April
29, 2008 |
ComplianceOnline |
GLP
Compliance Audits: What to look out for at a New Nonclinical
CRO |
David
Pepperl, Ph.D.
(speaker) |
on-line
seminar |
| April
28 - May 2, 2008 |
Cambridge
Healthtech Institute |
4th
Annual PEGS (Protein Engineering Summit)
"Implementation
of a flexible cGMP complaint Stability Program for Phase I,
II and III Studies" |
Nanda
Subbarao, Ph.D.
(speaker) |
Boston,
MA |
| April
24-25, 2008 |
International
Pharmaceutical Academy, Canada |
Developing
an Effective
Complaint Handling and Recalls Program |
Janice
Wilson, Ph.D.
(speaker) |
Toronto,
Canada |
| April
20-25, 2008 |
Society
of Quality Assurance (SQA) |
24th
SQA Annual Meeting and Training |
Carl
Anderson
(speaker)
Michael
Trapani, MS, MBA (speaker) |
Memphis,
TN |
| April
17, 2008 |
North
Carolina Biotechnology Center's Bioprocessing and Process Development
Group |
BioProcessing
& Process Development Intellectual Exchange Group
"Immune
Response to Protein Therapeutics" |
Nanda
Subbaro, Ph.D.
(speaker) |
Research
Triangle Park, NC |
| April
14-18, 2008 |
PDA |
2008
Annual Meeting
"Critical
Issues in the Vaccine Industry: A Review of Recent FDA Warning
Letters" (Wilson) |
Nadine
Ritter, Ph.D.
Janice
Wilson, Ph.D.
(speaker) |
Colorado
Springs, CO |
April
12 – 19, 2008
|
American
Academy of Neurology |
60th
Annual Meeting |
Wilson
W. Bryan, MD |
Chicago,
IL |
| April
7-9, 2008 |
CASSS |
European
CMC Strategy Forum |
Nadine
Ritter, Ph.D. |
Paris
France |
| April
3-5, 2008 |
AADR
American Associate for Dental Research |
Annual
Meeting |
Angela
Blackwell, MS |
Dallas,
TX |
| April
3, 2008 |
ComplianceOnline |
FDA
Expectations for Cell, Tissue and Gene Therapy Products |
David
J. Pepperl, Ph.D.
(speaker) |
on-line
seminar |
| March
28-29, 2008 |
AABB
(American Association of Blood Banks) |
Spring
Conference 2008
Regulatory
Considerations of Using Stem Cells for Cardiac Applications |
Ellen
M. Areman, MS, SBB
(speaker) |
Orlando,
FL |
| March
26-28, 2008 |
Reed
Life Sciences
|
PharmaMedDevice
Conference
"Combination
Products -- Regulatory: Applications & Documentation"
|
Stuart
Portnoy, MD
(speaker) |
Philadelphia,
PA
|
| March
26-28, 2008 |
Regulatory
Affairs Professional Society (RAPS) |
2008
Horizons Conference |
Ron
Marchesani
(speaker)
Janice
Wilson, Ph.D. |
San
Francisco, CA |
| March
18-19, 2008 |
British
Columbia Institute of Technology (BCIT) |
Design
and Implementation of Effective Stability Studies for Biotechnology
Products |
Nadine
Ritter, Ph.D.
(course director) |
Vancouver,
BC, Canada |
| March
16-20, 2008 |
Society
of Toxicology |
SOT
Annual Meeting and Tox Expo |
John
Jessop, Ph.D., MPH |
Seattle,
WA |
| March
13, 2008 |
ComplianceOnline |
Utilizing
ICH Guidelines for GCP Regulatory Compliance |
Carl
Anderson
(speaker) |
on-line
seminar |
| March
10-11, 2008 |
IBC
Life Sciences Training Academy |
Process
Validation for Biologicals Conference |
Ron
Marchesani |
San
Diego, CA |
| March
6-7, 2008 |
ASENT
(American Society of Experimental NeuroTherapeutics) |
Annual
Meeting |
Wilson
W. Bryan, MD
(course co-director) |
Washington,
DC |
| March
2-4, 2008 |
The
Barnett Institute |
Biogenerics
2008 |
Nanda
Subbaro, Ph.D. |
Boston,
MA |
| February
25-29, 2008 |
Seton
Hall Law School
|
Health
Care Compliance Certification Program
"Advertising
& Promotion of Medical Devices" |
Stuart
Portnoy, MD
(speaker) |
Newark,
NJ |
| February
21-22, 2008 |
Texas
Scottish Rite Hospital for Children |
30th
Annual Carrell-Krusen Neuromuscular Symposium |
Wilson
W. Bryan, M.D. |
Dallas,
TX |
| February
12-15, 2008 |
R&D
Directions |
5th
Annual Drug Development Summit 2008 |
David
T. Lin, Ph.D.
(speaker) |
Amelia
Island, FL |
| February
11-13, 2008 |
Pharmaceutical
Education and Research Institute (PERI), Inc. |
Effective
Planning & Management of Clinical Trials |
Wilson
W. Bryan, M.D.
(course co-director) |
Arlington,
VA |
| February
9-10, 2008 |
ISCTR
(International Society for Cardiovascular Translational Research) |
Annual
Meeting
"Regulatory
Considerations for Cell Manufacturing and Cell Delivery" |
Darin
Weber, Ph.D.
(speaker) |
San
Diego, CA |
| February
9-10, 2008 |
DIA
(Drug Information Association) |
21st
Annual DIA Conference for Electronic Document Management: Managing
Documents and Records |
Dan
Offringa
Kelly
Reich, MS
Holli
Vaughan, MS, RAC |
Philadelphia,
PA |
| January
28-30, 2008 |
Phacilitate |
Phacilitate
Cell & Gene Therapy Forum 2008 |
Andra
Miller, Ph.D.
Maritza
C. McIntyte, Ph.D.
Darin
Weber, Ph.D.
|
Washington
DC |
| January
28-29, 2008 |
International
Pharamceutical Academy (IPA) |
FDA
Pre-Approval Inspections
"FDA
approval processes and combination device and biologics inspections" |
John
R. Godshalk, MSE, MBA
(speaker) |
Toronto,
Canada |
| January
27-30, 2008 |
CASSS |
CMC
Strategy Forum
12th
Annual Symposium on the Interface of Regulatory and Analytical
Sciences for Biotechnology Health Products |
Nadine
Ritter, Ph.D.
(speaker)
Keith
Wells, Ph.D.
Ruth Wolff, Ph.D.
|
Washington, DC |
| January
27-30, 2008 |
CASSS |
CMC
Strategy Forum
Extractables
and Leachables: Challenges and Strategies in Biopharmaceutical
Development |
Keith
Wells, Ph.D.
Ruth Wolff, Ph.D.
|
Washington, DC |
| January
27-30, 2008 |
CASSS |
CMC
Strategy Forum
Current
Practices for Assessing the Comparability and Stability of
Gene Therapy Products |
Andra
Miller, Ph.D.
Maritza
C. McIntyte, Ph.D.
Nadine
Ritter, Ph.D.
(co-leader)
Darin
Weber, Ph.D.
|
Washington, DC |
| January
21-23, 2008 |
Institute
for International Research |
5th
Annual Formulation & Forced Degradation
"Implementation
of a flexible yet cGMP complaint Stability Program for Phase
I, II and III Studies" |
Nanda
Subbaro, Ph.D.
(speaker) |
San
Diego, CA |
| January
17 - 18, 2008 |
IBC
China |
US
FDA Biological Approval Process |
Lei
Zhang, MD, Ph.D.
(speaker) |
Taipei,
Taiwan |
| January
14 - 16, 2008 |
ALS
Association |
ALSA
Research Workshop |
Wilson
W. Bryan, M.D.
(speaker) |
Tampa,
FL |
| January
14 - 15, 2008 |
IBC
China |
US
FDA Biological Approval Process |
Lei
Zhang, MD, Ph.D.
(speaker) |
Seoul,
South Korea |
| December
20, 2007 |
Pennsylvania
BIO & Nanotechnology
Institute & Ben
Franklin Technology Partners |
Overcoming
Barriers Faced When Bringing a Bio-Nanotechnology Product to
Market
|
Stuart
Portnoy, MD
|
Philadelphia,
PA |
| December
13 - 14, 2007 |
IBC
China |
US
FDA Biological Approval Process |
Lei
Zhang, MD, Ph.D.
(speaker) |
Beijing,
China |
| December
7 - 11, 2007 |
American
Society of Hematology |
49th
Annual Meeting and Exposition |
Liana
Harvath, Ph.D. |
Atlanta,
GA |
| November
12-15, 2007 |
AAPS
(American Association of Pharmaceutical Scientists) |
AAPS
Annual Meeting
“Critical
Stability Evaluation of Biopharmaceuticals During Clinical
Development” |
David
T. Lin, Ph.D.
(speaker) |
San
Diego, CA |
| November
12-14, 2007 |
ACT
(American College of Toxicology) |
Annual
Meeting |
Melanie
Hartsough, Ph.D.
John
Jessop, Ph.D., MPH
David
J. Pepperl, Ph.D. |
Charlotte, NC |
| November
12-13, 2007 |
Pharma
Conference |
Current
GMP Concepts: Focus on Biologics |
Eugene
Johnston, CQE, CQA |
San
Antonio, TX |
| November
8-9, 2007 |
FDA-HHS-NIAID
workshop |
Anthrax
Vaccines- Bridging Correlates of Protection in Animals and Immunogenicity
in Humans |
Ann
Sutton |
Gaithersburg,
MD |
| November
5-7, 2007 |
Informa
Life Sciences
|
Medical
Device Regulations: Essential Training in Present and Pending
Medical Device Regulations
"Introduction
to US FDA Regulations"
|
Stuart
Portnoy, MD
(speaker)
|
Munich,
Germany
|
| October
23, 2007 |
Second
Annual FDA Inspections Summit |
Getting
it Right the First Time, Every Time
"Combination
and Device Inspections" Godshalk
"Essential
Documents: Auditing Trial Master Files" Anderson |
John
R. Godshalk, MSE, MBA
(speaker)
Carl
Anderson
(speaker) |
Bethesda, MD |
| October
20 - 23, 2007 |
AABB
(American Association of Blood Banks) |
Annual
Meeting & TXPO 2007
“New
Technologies in Cellular Product Testing” |
Ellen
M. Areman, MS, SBB
(moderator) |
Anaheim,
CA |
| October
8 - 9, 2007 |
BioNJ and Pennsylvania Bio |
Biotech
2007 |
Joe
Clancy - BCG Board of Directors
Michael
Trapani, MS, MBA
Keith
Wells, Ph.D. |
Philadelphia,
PA |
| October
2 - 3, 2007 |
|
2007
International Symposium on Regulation of Human Cell and Tissue-Based
Products
"FDA
Regulations and Practices for Human Cell and Tissue-Based
Therapies/Products"
"Biosafety and Manufacturing Considerations for Clinically
Cell-Based Therapies" |
Darin
Weber, Ph.D.
(speaker) |
Taipei,
Taiwan |
| October
2 - 3, 2007 |
IVT
Lab Week |
Capturing
the Science of Stability Testing
"Out-of
-Specification Investigations for Stability Samples" |
Nanda
Subbaro, Ph.D.
(speaker) |
San
Diego, CA |
| September
26, - 28, 2007 |
ISCT |
Somatic
Cell Therapy Symposium
“Use
of Devices in Cell Therapy Manufacturing” |
Ellen
M. Areman, MS, SBB
(session
moderator)
Liana
Harvath, Ph.D.
(session moderator) |
Bethesda,
MD |
| September
23- 26, 2007 |
Regulatory
Affairs Professional Society (RAPS) |
Annual
Conference & Exhibition
"Regulatory
Considerations for Starting a Gene Therapy Trial in the US"
(Miller)
"Facility
Design Considerations for Biologics" (Godshalk)
"Addressing
Immunogenicity of Biotechnology-Derived Therapeutic Products:
Preclinical, Clinical and Analytical Considerations"
(Subbarao)
"Quality
Expectations for Product Development CMC Activities: R&D,
GLP or GMP" (Weber) |
Speakers
Andra
Miller, Ph.D.
John
R. Godshalk, MSE, MBA
Nanda
Subbaro, Ph.D.
Darin
Weber, Ph.D.
John
Jessop, Ph.D., MPH
Ron
Marchesani
Reggie
Neal
Kelly
Reich, MS
Holli
Vaughan, MS, RAC
Keith
Wells, Ph.D.
|
Boston,
MA |
| September
17 - 21, 2007 |
University
of Wisconsin-Madison |
10th
Annual Land O'Lakes Conference on Drug Metabolism/Applied Pharmacokinetics |
Melanie
Hartsough, Ph.D.
(speaker) |
Merrimac,
WI |
| September
10 - 12, 2007 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS
Workshop on Stability: Developing a Stability Program for
the Global Market
Stability
Challenges of OTCs, Nutraceuticals and Combination Products |
Nanda
Subbaro, Ph.D.
(moderator) |
North
Bethesda, MD |
| August
21 - 24, 2007 |
Cambridge
Healthtech Institute |
Target
Immunotherapeutics and Vaccine Summit
"Selecting
a Study Population" |
Stephen
Litwin, MD
(speaker) |
Cambridge,
MA |
| June
27 - 28, 2007 |
Pharmaceutical
Training Institute |
“Design
and Implement Effective Stability Programmes for Biotechnology
Products” |
Nadine
Ritter, Ph.D.
(speaker) |
London,
England |
| June
19 - 20, 2007 |
IVT
Method Validation Conference |
"Test
Method Qualification or Test Method Validation: What is the
Difference?" |
Nadine
Ritter, Ph.D.
(speaker) |
Brussels, Belgium |
| June
18 - 20, 2007 |
BIO |
VentureForum
East 2007 |
Wilson
W. Bryan, M.D.
(speaker) |
Montreal,
Canada |
| June
18-21, 2007 |
Drug
Information Association (DIA) |
43rd
Annual Meeting
“The
Impact of FDA's Quality-by-design Initiative on Biologics
Development” |
David
T. Lin, Ph.D.
(speaker) |
Atlanta,
GA |
| June
17 - 23, 2007 |
|
Options
for Control of Influenza VI |
Mike
Williams |
Toronto,
Canada |
June
12 - 13, 2007
|
IBC
Life Sciences Training Academy |
"Best
Practices for Biotechnology Product Comparability and Stability
Studies -
Protocols, Test Methods and Quality Practices" |
Nadine
Ritter, Ph.D.
(speaker) |
Seattle,
WA |
| May
30 - Jun 3, 2007 |
ASGT
(American Society of Gene Therapy) |
10th
Annual Meeting |
Maritza
C. McIntyre, Ph.D.
(speaker)
|
Seattle,
WA |
| May
21 - 22, 2007 |
IVT
Method Validation Conference |
"Test
Method Qualification or Test Method Validation: What is the
Difference?" |
Nadine
Ritter, Ph.D.
(speaker) |
Boston, MA |
| May
15 - 16, 2007 |
IBC
Life Sciences Training Academy |
"Best
Practices for Biotechnology Product Comparability and Stability
Studies -
Protocols, Test Methods and Quality Practices" |
Nadine
Ritter, Ph.D.
(speaker) |
Boston,
MA |
| May
7 - 9, 2007 |
Pharmaceutical
Education Research Institute (PERI) |
Effective
Planning and Management of Clinical Trials |
Wilson
Bryan, M.D.
(Course
Co-Director ) |
Arlington,
VA |
| May
6 - 9, 2007 |
BIO
(Biotechnology Industry Organization) |
BIO
2007 (Booth #2281) |
Jim Kenimer, Ph.D.
& Others |
Boston,
MA |
| Apr.
28 - May 5, 2007 |
American
Academy of Neurology |
59th
Annual Meeting |
Wilson
W. Bryan, M.D. |
Boston,
MA |
| Apr.
23 - 27, 2007 |
BioProcess
International European Conference |
"Workshop
on Stability Testing For Biological Drugs" and "Workshop
on Managing CMC Changes from a Regulatory Perspective" |
Nadine
Ritter, Ph.D.
(speaker) |
Paris,
France |
| Apr.
11 - 12, 2007 |
IBC
Life Sciences Training Academy |
"Best
Practices for Biotechnology Product Comparability and Stability
Studies -
Protocols, Test Methods and Quality Practices" |
Nadine
Ritter, Ph.D.
(speaker) |
San
Diego, CA |
| Mar.
28 - 30, 2007 |
Regulatory
Affairs Professional Society (RAPS) |
RAPS
2007 Horizons Conference & Exhibition |
Sarah
McNulty, RAC |
San
Francisco, CA |
| March
25-28, 2007 |
Society
of Toxicology |
SOT
Annual Meeting |
John
Jessop, Ph.D.
David
Pepperl, Ph.D.
Tanya
Kersten, Ph.D. |
Charlotte,
NC |
| Mar.
23-27, 2007 |
AABB |
Spring
Cell Therapy Conference
Moderating
session on Novel Cell Therapies |
Ellen
M. Areman, MS, SBB
John
R. Godshalk, MSE, MBA
(speakers) |
San
Diego, CA |
| Mar.
19 - 22, 2007 |
Terapinn |
World
Vaccine Congress 2007
Agenda |
Peter
Patriarca, M.D.
(chairman)
Julia
Barrett, M.D., MPH
David
Pepperl, Ph.D.
Nadine
Ritter, Ph.D.
Keith
Wells, Ph.D.
(speakers) |
Washington,
DC |
| March
19-21, 2007 |
Institute
for International Research (IIR) |
Formulation
and Forced Degradation Strategies for Biomolecules
“Regulatory
Requirements for Successful Product Development”
|
David
T. Lin, Ph.D.
(speaker) |
San
Diego, CA |
| Mar.
14 - 17, 2007 |
Mayo
Clinic |
Oncolytic
Virus Conference |
Maritza
C. McIntyte, Ph.D.
(speaker) |
Carefree,
AZ |
| Mar.
14 - 15, 2007 |
Pharmaceutical
Training Institute |
“Design
and Implement Effective Stability Programmes for Biotechnology
Products” |
Nadine
Ritter, Ph.D.
(speaker) |
London,
England |
| Mar.
8 - 10, 2007 |
California
Separation Science Society (CASSS) |
EU
CMC Strategy Forum
“Life
Cycle Approach to Establishing Biotechnology Product Specifications” |
Nadine
Ritter, Ph.D.
(speaker) |
Brussels,
Belgium |
| Mar.
8 - 10, 2007 |
American
Society for Experimental NeuroTherapeutics (ASENT) |
Annual
Meeting |
Wilson
W. Bryan, M.D.
(Course
Co-Director ) |
Washington,
DC |
| Feb.
28 - Mar. 2 |
Cambridge
Healthtech Institute |
2nd
Annual Commercial Implications of Stem Cell Research
Track
6 at Molecular Medicine Tri-Conference; Panel Expert on Regulatory
Issues for Neural Regeneration |
Darin
Weber, Ph.D.
(speaker) |
San
Francisco, CA |
| Feb.
22-23, 2007 |
|
Carrell-Krusen
Symposium
|
Wilson
W. Bryan, M.D. |
Dallas,
Texas |
| Feb.
12-13, 2007 |
International
Pharmaceutical Academy (IPA) |
Effective
Management of Stability Programs
“Stability
Design Considerations for Global Regulatory Filings” |
David
T. Lin, Ph.D.
(speaker) |
Toronto,
Canada |
| Jan.
22-24, 2007 |
Phacilitate |
Cell
& Gene Therapy Forum 2007 |
Darin
Weber, Ph.D. |
Baltimore,
MD |
| Jan.
22-24, 2007 |
IIR |
4th
Annual Forced Degradation Studies |
David
T. Lin, Ph.D.
(speaker) |
Las
Vegas, NV |
| Jan.
9-10, 2007 |
Cambridge
Healthtech Institute |
PepTalk:
Optimizing Protein and Antibody Therapeutics |
David
T. Lin, Ph.D.
(speaker) |
San
Diego, CA |
| Dec.
6-7, 2006 |
PTI
(Pharmaceutical Training Institute |
Stability
Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.
(course instructor) |
London,
UK |
| Nov.
6-8, 2006 |
Williamsburg
BioProcessing Foundation |
WilBion
Viral Vectors and Vaccines Meeting
"WilBion
Viral Vectors and Vaccines Meeting" |
Maritza
C. McIntyte, Ph.D.
(speaker) |
Southampton,
Bermuda |
| Nov.
1-3, 2006 |
FDANews |
FDA
Inspections Summit: Getting it Right the First Time, Every Time |
John
Godshalk, MSE, MBA |
Rockville,
MD. |
| Oct.
29 - Nov. 2, 2006 |
AAPS |
2006
AAPS Annual Meeting
“The
Impact of FDA Initiatives on the Development of Biological
Products”
|
David
T. Lin, Ph.D.
(speaker) |
San
Antonio, TX |
| Oct.
21-22, 2006 |
AABB |
Annual
Meeting
"Regulation
of Cell Therapy Products for Cardiac Disease" |
Ellen
M. Areman, MS, SBB
(speaker) |
Miami
Beach, FL |
| Oct.
19-20, 2006 |
SWE
Enterprises |
Stability
Testing for the FDA Regulated Industry
“Cost
Efficient Design of Stability Studies”
“In-Use
Testing of Biotechnological and Biologic Products”
|
David
T. Lin, Ph.D.
(speaker) |
Boston,
MA |
| Oct.
16-17, 2006 |
DIA |
First
International DIA Workshop on “Developing Probiotics
as Foods and Drugs – Scientific and Regulatory Challenges” |
Ann
Sutton |
University
of Maryland College Park Campus |
| Oct.
16-17, 2006 |
SRI
Institute |
6th
Annual Stem Cells and Regenerative Medicine Meeting |
Darin
Weber, Ph.D. |
Pittsburgh,
PA |
| Oct.
15-18, 2006 |
Regulatory
Affairs Professional Society (RAPS) |
Annual
Conference & Exhibition |
Jim
Kenimer, Ph.D.
Speakers
Ellen
M. Areman, MS, SBB
Bette
A. Goldman, RN, MPH
Stephen
Litwin, MD
Maritza
C. McIntyte, Ph.D.
Attendees
John
Jessop, MPH, Ph.D.
Tanya
Kersten, Ph.D.
Dan
Offringa
Kelly
Reich
Holli
Vaughan, MS, RAC
Mike
Williams |
Baltimore,
MD |
| Sept.
25-27, 2006 |
ISCT/FDA |
Somatic
Cell Therapy Symposium
Moderating
session on Release Testing of Cell Therapy Products |
Ellen
M. Areman, MS, SBB
Stephen
Litwin, MD |
Bethesda,
MD |
| July
20-21, 2006 |
CaSSS |
WCBP
CMC Strategy Forum
"Changing
Paradigms in Process Validation" |
Nadine
Ritter, Ph.D.
(speaker) |
NIH
campus
Bethesda, MD |
| June
29 - July 1, 2006 |
International
Society for Stem Cell Research (ISSCR) |
4th
Annual Meeting |
Jim
Kenimer, Ph.D.
Ellen
Areman, MS, SBB
Darin
Weber, Ph.D. |
Toronto,
Ontario |
| June
28-29, 2006 |
IBC
Life Sciences |
IBC
Life Sciences Training Academy 2006
"Best
Practices for Biotechnology Product Comparability and Stability
Studies: Protocols, Test Methods, and Quality Products" |
Nadine
Ritter, Ph.D.
(course instructor) |
Boston,
MA |
| June
20-23, 2006 |
IVT |
Stability
Testing: Implementing Effective Processes for Stability Program
Development
"Cost
Efficient Design of Stability Studies"
"Stability
Requirements for Global Regulatory Filings" |
David
Lin, Ph.D.
(speaker) |
San
Diego, CA |
| June
19-21, 2006 |
American
Association of Pharmaceutical Scientists' (AAPS) |
2006
National Biotechnology Conference
"Regulatory
Issues in Developing New Vaccines" |
Peter
Patriarca, M.D.
(speaker) |
Boston,
MA |
| June
17-19, 2006 |
IBC
Life Sciences |
IBC
International Analytical Summit: Implementing Process Analytical
Technologies (PAT) for Bioprocessing
"Overcoming
Challenges for the PAT Implementation Team" |
Nadine
Ritter, Ph.D.
(workshop facilitator) |
Reston,
VA |
| June
11-12, 2006 |
IIR |
Chemistry,
Manufacturing & Control (CMC)
“Clarifying
and Understanding ICH Guidance to Help Meet International
Requirements for Submissions”
|
David
Lin, Ph.D.
(speaker) |
Philadelphia,
PA |
| June
8-9, 2006 |
CBI
(Center for Business Intelligence) |
Stability
Programs: New Approaches to Test, Analyze and Document Data
for Improved Program Design and Global Compliance
"In
Use Testing of Biotechnological and Biological Products" |
David
Lin, Ph.D.
(speaker) |
Princeton,
NJ |
| May
31 - June 4 |
ASGT
(American Society of Gene Therapy) |
9th
Annual Meeting |
Jim
Kenimer, Ph.D.
& Others
|
Baltimore,
MD |
| May
24-25, 2006 |
IBC
Life Sciences |
IBC
Life Sciences Training Academy 2006
"Best
Practices for Biotechnology Product Comparability and Stability
Studies: Protocols, Test Methods, and Quality Products" |
Nadine
Ritter, Ph.D.
(course instructor) |
Seattle,
WA |
| May
16-18, 2006 |
IVT
(Institute for Validation Technology) |
Annual
Method Validation Conference
"What
is Test Method Qualification" |
Nadine
Ritter, Ph.D.
(speaker) |
Dublin,
Ireland |
| May
10-11, 2006 |
PTI
(Pharmaceutical Training Institute |
Stability
Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.
(course instructor) |
London,
UK |
| May
4-7, 2006 |
ISCT
(International Society for Cellular Therapy) |
12th
Annual Meeting
Cellular
Therapy for Cardiac Applications |
Ellen
Areman, MS, SBB |
Berlin
Germany |
| May
4, 2006 |
University
of Maryland, Baltimore County |
Department
of Chemical and Biochemical Engineering Course, ENCH 662 -
Good Manufacturing Practices for Bioprocesses
"Assay
Development and Validation" |
Nadine
Ritter, Ph.D.
(speaker) |
UMBC
Colesville Campus |
| May
1-4, 2006 |
IBC
Life Sciences |
TIDES
2006:
Oligonucleotide and Peptide ® Technology and Product Development
-Practical Considerations for Saving Time and Money while Ensuring
Quality
"Stability
Considerations and Testing for Oligo- and Peptide-Based Therapeutics" |
David
Lin, Ph.D.
(speaker) |
Carlsbad,
CA |
| Apr.
26-27, 2006 |
IBC
Life Sciences |
IBC
Life Sciences Training Academy 2006
"Best
Practices for Biotechnology Product Comparability and Stability
Studies: Protocols, Test Methods, and Quality Products" |
Nadine
Ritter, Ph.D.
(course instructor) |
Philadelphia,
PA |
| Apr.
9 - 12, 2006 |
BIO
(Biotechnology Industry Organization) |
BIO
2006 |
Jim Kenimer, Ph.D.
& Others |
Chicago,
IL |
| Apr.
3-5, 2006 |
PERI
(Pharmaceutical Education and Research Institute ) |
Biologics
Drug Development: An Integrated Overview of Manufacturing,
Nonclinical, Clinical, and Regulatory Requirements
"Key
CMC Biopharmaceutical Product Development Studies"
"Key
CMC Biopharmaceutical Process Development Studies"
"Overview
of Clinical Trial Design"
|
Nadine
Ritter, Ph.D.
(speaker)
Ruth Wolff, Ph.D.
(speaker)
Barbara
G. Matthews, MD, MPH
(BCG Affiliate, speaker) |
Bethesda,
MD |
| Mar.
21, 2006 |
Carilion
Biotech Association |
|
John
Jessop, MPH, Ph.D.
(speaker) |
Roanoke,
VA |
| Mar.
8-9, 2006 |
PTI
(Pharmaceutical Training Institute |
Stability
Testing for Biotechnology Products |
Nadine
Ritter, Ph.D.
(course instructor) |
London,
UK |
| Feb.
22, 2006 |
Molecular
Medicine Tri-Conference |
Commercial
Implications of Stem Cell Research
Lost
in Translation? - Addressing Regulatory Concerns While Bridging
from Research to Clinical Applications of Stem Cells |
Darin
Weber, Ph.D.
(speaker) |
San
Francisco, CA |
| Jan.
30 - Feb. 1, 2006 |
Phacilitate |
Phacilitate
Vaccine Forum |
Jim
Kenimer, Ph.D.
Peter
Patriarca, M.D.
Mike
Williams |
Baltimore,
MD |
| Jan.
25, 2006 |
CaSSS |
WCBP
2006: 10th Symposium on the Interface of Regulatory and Analytical
Sciences For Biotechnology Health Products
Workshop:
Co-Chair: A New Class of “Live” Therapy |
Darin
Weber, Ph.D.
(speaker) |
San
Francisco, CA |
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August 16, 2010
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