The science, regulatory and business leaders who are building the future of our industry are attending this year’s GRx+Biosims, which takes place November 4-6 in North Bethesda, MD. Find out more and register today.
The 2019 version promises extensive opportunities for education and engagement. Many registrants have told us they are especially excited about the exposition scheduled for 3:30-5:30 p.m. on Tuesday, November 6. Designed to facilitate one-on-one interaction, this session brings together influential representatives spanning scientific disciplines and sectors—industry, academia and agency.
"The scientific exposition represents a unique knowledge-sharing opportunity," says Lisa Parks, Sciences & Regulatory Affairs Vice President at AAM. "FDA and industry scientific and regulatory experts will be on hand to have a one-on-one interactive dialogue with attendees. I look forward to welcoming scientific and regulatory minds from all over the world to our scientific exposition."
The growing list of exposition participants includes leaders from the following FDA offices:
- Office of Generic Drugs (OGD)
- Office of Regulatory Operations (ORO)
- Office of Research and Standards (ORS)
- Office of Bioequivalence (OB)
- Office of Pharmaceutical Quality (OPQ)
- Knowledge Aided Assessment and Structured Application (KASA)
- Office of Regulatory Affairs (ORA)
- Office of Management (OM)
The exposition also includes the following topics covered by industry stakeholders:
- Best Practices and Robust Strategies for DMF
- Access to Medicine is Access to Hope
- Challenges and Opportunities: Complex Products and Bioequivalence Studies
- Risk Management Considerations for Combination Products
- Orange you glad we know how to fix the Purple Book
- Industry Feedback in Preparation for GDUFA 3
- Quality Initiatives for ANDAs
- Serialization from a CMO Partnership Perspective
- Combination Products – The Intersection of the 300 and 800s in your ANDA
- Transfer of Assets in a Regulated Environment
- The Sandoz Perspective on Biosimilar Interchangeability: A Designation Unique to the United States
- Deficiency Trending – A Pharmaceutical Quality Tool
View the GRx+Biosims Agenda. I look forward to seeing you in November!
By Jennifer Soup, AAM Director of Meetings & Marketing