Science and Regulatory Affairs
Task Forces
By joining a PDA Task Force, you will contribute to the development or revision of highly-valued industry guidance or the preparation of PDA comments on regulatory issues of a global nature, while collaborating with a team of subject-matter experts from industry, academia and/or government agencies.
Highly-Valued Industry Guidance: PDA Technical Reports or Technical Bulletins
PDA Technical Reports and Bulletins are unique PDA products that offer expert guidance, best practices, and opinions on variety of important scientific and regulatory topics pertaining to pharmaceutical and biopharmaceutical production. Each document is vetted through the PDA peer review process-including review and approval by PDA's Biotech Advisory Board and/or Science Advisory Board and Regulatory Affairs and Quality Advisory Board and the PDA Board of Directors before they are published.
Proposed Regulations and Guidance
PDA develops comments on proposed new initiatives advanced by global regulatory agencies to help ensure that new regulations and regulatory guidance have a strong science base. PDA comments are reviewed by the Regulatory Affairs and Quality Advisory Board and the PDA Board of Directors before they are submitted to the pertinent Regulatory Authority. These comments are reviewed and evaluated by these Authorities as they finalize new regulations and guidance.
For more information about the PDA Biotechnology Advisory Board, contact sci_reg@pda.org.
List of BioAB-Sponsored Task Forces
Analytical Methods Development for Biotechnology Products
Task Force Leaders: Melissa Smith, MJ Quality Solutions
Analytical Methods Validation for Commercial Biopharmaceutical Products
Task Force Leader: Stephan O. Krause, MedImmune
Bioburden and Biofilm Management
Task Force Leader: Vince R. Anicetti
Cell Substrates
Task Force Leader: Kathryn King, Ph.D., Food and Drug Administration/CDER and Michael Wiebe, Ph.D., Quantum Consulting, LLC
Single Use Systems
Task Force Leader: Robert Repetto, Pfizer
Mycoplasma: Contamination and Control
Task Force Leader: Barbara J. Potts, Ph.D., Potts and Nelson Consultants, LLC