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PBOA Regulatory/Legislative Workshop
March 30, 2015 @ 10:00 am - 4:00 pm
Rescheduled from March 5
This free, members-only workshop in Washington, DC will cover legislative and regulatory topics critical to CMOs and CDMOs. Speakers will include both FDA and industry experts, and each presentation will be followed with time for Q&A.
- 10:00-10:30 a.m.: Legislative Trends and the new Congress • Alan Parver, Arnall Golden Gregory
- 10:30 a.m.- 11:30 a.m.: FDA: GDUFA and CDMOs • Keith Flanagan – Director of the Office of Generic Drug Policy, FDA/CDER/OGD/OGDP
- 11:30-noon: CDMO Landscape • Jim Miller – President, PharmSource
- 1:00-2:00 p.m.: FDA: Compliance and Enforcement – Quality Agreements Between CMOs and Clients • Paula Katz – Director, Manufacturing Quality Guidance and Policy, FDA/CDER/OMPQ
- 2:00-3:00 p.m.: FDA Quality Metrics Initiative • Denyse Baker – Senior Advisor, Scientific and Regulatory Affairs, PDA
- 3:00-4:00 p.m.: Preparing the CMO/CDMO Business for the Global Serialization Tsunami • Graham Clark – Global Head of CMO/CPO Partnerships, Tracelink
This workshop is free, but is only open to members of the Pharma & Biopharma Outsourcing Association. To learn more about joining the PBOA, click here!
Are you a PBOA member interested in attending this event? RSVP here!