Agenda
3:00 PM — 3:10 PM
3:10 PM — 3:20 PM
US Food and Drug Administration (US FDA)3:20 PM — 3:25 PM
Central Drugs Standard Control Organization (CDSCO) Representative3:25 PM — 3:30 PM
UK Medicines And Healthcare Products Regulatory Agency (MHRA)3:30 PM — 3:35 PM
European Medicines Agency (EMA)3:35 PM — 3:55 PM
Maintaining GCP During COVID-19 and Beyond - an EMA Perspective3:55 PM — 4:15 PM
MHRA Inspections During The Pandemic4:15 PM — 4:35 PM
CDSCO Presentation4:35 PM — 5:00 PM
5:00 PM — 5:30 PM
US FDA Generic Drug Application Overview During COVID-196:00 PM — 6:30 PM
Regulatory Expectations During COVID-196:30 PM — 6:45 PM
Office of Generic Drugs Global Program6:45 PM — 7:00 PM
Question and Answer Session for the presentations7:00 PM — 8:00 PM
Industry Lessons Learned during COVID-19 Pandemic8:00 PM — 8:15 PM
3:00 PM — 3:15 PM
4:00 PM — 4:30 PM
Quality in Electronic Data- an EMA Perspective4:30 PM — 5:00 PM
US FDA Perspective : Building Quality into Clinical Trial Data5:30 PM — 5:45 PM
Question and Answer Session for the presentations5:45 PM — 6:00 PM
6:00 PM — 6:30 PM
US FDA GLP Inspection Findings in India7:00 PM — 8:00 PM
Regulatory Round Table8:00 PM — 8:15 PM
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