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.
Contribute to a Highly-Valued Industry Guidance: Help Write a PDA Technical Report or Technical Bulletin
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 Science Advisory Board and/or Biotechnology Advisory Board and the PDA Board of Directors-before they are published.
Comments on Proposed Regulations and Guidances
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 Committee 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 RAQAB, contact firstname.lastname@example.org.
GMP Considerations for Manufacture of Investigational Drug Product
Task Force Leaders: Karen Ginsbury, PCI Pharmaceutical
Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials
Task Force Leader: Vince Mathews, Eli Lilly and Company, and Katherine Greene, Novartis Pharmaceuticals