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X-WR-CALDESC:Events for PBOA
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DTSTART:20140101T000000
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BEGIN:VEVENT
DTSTART;TZID=UTC:20150330T100000
DTEND;TZID=UTC:20150330T160000
DTSTAMP:20260607T220341
CREATED:20150204T190638Z
LAST-MODIFIED:20150324T221256Z
UID:7918-1427709600-1427731200@pharma-bio.org
SUMMARY:PBOA Regulatory/Legislative Workshop
DESCRIPTION:Rescheduled from March 5 \nThis 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. \n\n\n10:00-10:30 a.m.: Legislative Trends and the new Congress • Alan Parver\, Arnall Golden Gregory\n10:30 a.m.- 11:30 a.m.: FDA: GDUFA and CDMOs • Keith Flanagan – Director of the Office of Generic Drug Policy\, FDA/CDER/OGD/OGDP\n11:30-noon: CDMO Landscape • Jim Miller – President\, PharmSource\n1:00-2:00 p.m.: FDA: Compliance and Enforcement – Quality Agreements Between CMOs and Clients • Paula Katz – Director\, Manufacturing Quality Guidance and Policy\, FDA/CDER/OMPQ\n2:00-3:00 p.m.: FDA Quality Metrics Initiative • Denyse Baker – Senior Advisor\, Scientific and Regulatory Affairs\, PDA\n3:00-4:00 p.m.: Preparing the CMO/CDMO Business for the Global Serialization Tsunami • Graham Clark – Global Head of CMO/CPO Partnerships\, Tracelink\n\n\nThis workshop is free\, but is only open to members of the Pharma & Biopharma Outsourcing Association. To learn more about joining the PBOA\, click here! \nAre you a PBOA member interested in attending this event? RSVP here!
URL:https://pharma-bio.org/event/pboa-regulatorylegislative-workshop/
LOCATION:Unnamed Venue\, Washington\, DC\, United States
ORGANIZER;CN="PBOA":MAILTO:gil.roth@pharma-bio.org
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