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In 2002 it was SARS, followed by the avian flu and now H1N1, which pushed regulators and the vaccine industry to work collectively to overcome these threats. The recent H1N1 pandemic showed that joint efforts can result in fast track and robust activities to stifle the spread of the disease. The vaccine industry has been quick and flexible to produce the desired vaccine needed and the regulators responded with focus and speed to approve the necessary vaccine. This collaborative effort has given us “lessons learned” and these lessons are of high value to any member of the vaccine industry and regulatory authorities. Discuss with both industry experts and regulatory representatives these lessons and best practices at the 2010 PDA/FDA Vaccine Conference.
FDA speakers include:
* Raj K. Puri, MD, PhD, Director, Division of Cellular and Gene Therapies, CBER, FDA
* Jeremy L. Wally, PhD, Senior Regulatory Review Officer, CBER, FDA
* Arifa Khan, PhD, Supervisory Microbiologist, CBER, FDA
* Carmen M. Collazo, PhD, Microbiologist, CBER, FDA
* Phillip R. Krause, MD, Assoc.
* Dir. For Medical Policy & Vaccine Safety, CBER, FDA
* Sharon L. O'Callaghan, Consumer Safety Officer, CBER, FDA
* Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
* And more!
Industry speakers include:
* John W. Boslego, MD, Director,
* Vaccine Development Global Program, PATH
* Bruce Gellin, MD, MPH,
* Director, National Vaccine
* Program Office
* Kathryn Zoon, PhD, National
* Institute of Allergy and
* Infectious Diseases (NIAID)
* Diane Lejeune, PhD, Senior Manager, Medical Affairs, GlaxoSmithKline Biologicals
* Jefferey T. Jones, Director of
* Quality Assurance, Emergent
* Biodefense Operations
* Charles W. Nicholls, Jr.,
* Senior Director of Supply Chain Operations, MedImmune, LLC
* And more!
In 2002 it was SARS, followed by the avian flu and now H1N1, which pushed regulators and the vaccine industry to work collectively to overcome these threats. The recent H1N1 pandemic showed that joint efforts can result in fast track and robust activities to stifle the spread of the disease. The vaccine industry has been quick and flexible to produce the desired vaccine needed and the regulators responded with focus and speed to approve the necessary vaccine. This collaborative effort has given us “lessons learned” and these lessons are of high value to any member of the vaccine industry and regulatory authorities. Discuss with both industry experts and regulatory representatives these lessons and best practices at the 2010 PDA/FDA Vaccine Conference.
FDA speakers include:
* Raj K. Puri, MD, PhD, Director, Division of Cellular and Gene Therapies, CBER, FDA
* Jeremy L. Wally, PhD, Senior Regulatory Review Officer, CBER, FDA
* Arifa Khan, PhD, Supervisory Microbiologist, CBER, FDA
* Carmen M. Collazo, PhD, Microbiologist, CBER, FDA
* Phillip R. Krause, MD, Assoc.
* Dir. For Medical Policy & Vaccine Safety, CBER, FDA
* Sharon L. O'Callaghan, Consumer Safety Officer, CBER, FDA
* Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
* And more!
Industry speakers include:
* John W. Boslego, MD, Director,
* Vaccine Development Global Program, PATH
* Bruce Gellin, MD, MPH,
* Director, National Vaccine
* Program Office
* Kathryn Zoon, PhD, National
* Institute of Allergy and
* Infectious Diseases (NIAID)
* Diane Lejeune, PhD, Senior Manager, Medical Affairs, GlaxoSmithKline Biologicals
* Jefferey T. Jones, Director of
* Quality Assurance, Emergent
* Biodefense Operations
* Charles W. Nicholls, Jr.,
* Senior Director of Supply Chain Operations, MedImmune, LLC
* And more!
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