Regulatory Workshop Program & Presentations

The 2016 PPTA Regulatory Workshop, "Regulatory Challenges for Global Access to Therapies," was held Monday, June 13 in conjunction with the Plasma Protein Forum. 

In Session I, the workshop explored the sustainability of current U.S. Food and Drug Administration (FDA) lot release requirements, ie., polio and measles, for immune globulins. Companies need access to the polio virus to assess antibody levels for lot release; however, the World Health Organization’s polio eradication program may make it difficult, if not impossible, to obtain and work with the virus in the future. On the other hand, measles titers have continued to decline in the donor population since the 2007 FDA workshop on Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing. Data were presented from studies to monitor the antibody titers in donors and to boost the titers by vaccination. In light of these challenges, what are the future for these two lot release requirements? Industry, FDA, and a patient advocate explored these challenges and discussed potential impacts to industry and patients.

In Session II, the workshop highlighted current diversity in regulatory requirements related to post-market change reporting throughout the world. Lack of harmonization in change reporting makes it more difficult to plan and effect needed changes throughout a product’s lifecycle. Industry discussed the value of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, in addressing these challenges. Workshop participants then learned, through case study of company experience outside of the U.S. and the EU, how post-market changes can be managed in a diverse regulatory landscape. Workshop participants also had an opportunity to share their experiences and lessons learned.

Agenda

1:00 PM

Welcome
Jan M. Bult, President & CEO, PPTA
1:10 PM

Sustainability of Polio & Measles as FDA Release Tests for IG Products
Moderator: Mary Gustafson, PPTA
  Measles Antibody Titers in Plasma Donors
Toby Simon, CSL Behring
1:30 PM

Functional IVIG Release by Virus Neutralization Assays:
Measles, Polio, and Beyond …
Thomas R. Kreil, Shire
2:30 PM FDA’s Current Considerations
Dorothy Scott, FDA
3:00 PM Break
3:30 PM

Patient Advocate Perspective
Marcia Boyle, President & Founder, Immune Deficiency Foundation
4:00 PM Panel Q&A
4:20 PM

Session II: Managing Post-Market Changes in Diverse Regulatory Landscape
Moderator: Mary Clare Kimber, PPTA
  Global Complexity of Post-Approval Changes: Update on ICH Q 12
Bryan Silvey, Shire
4:40 PM

Case Studies: Non-EU Europe and Asia
Mirella Calcinai, Kedrion
5:00 PM Panel Q&A
5:15 PM Closing
Roger Brinser, Chair, PPTA Regulatory Policy & Compliance Steering Committee
5:30 PM END

 

Presentations