DIA’s 1st Workshop on Pre-market Evaluation of Quality and Bioavailability

This workshop will clarify the approval requirements for drugs developed in India for global markets. You will have the opportunity to participate in the exchange of alternative perspectives from industry, academia, and regulatory professionals.

FEATURED TOPICS:

·Current regulatory requirements for pre-market applications

·Current challenges facing quality and bioavailability

Vilayat A. Sayeed, PhD

Director, Division of Chemistry III

FDA/CDER/OPS/OGD.

Dr. Stephanie Parra

Manager of Generic Drugs: Quality Division

Bureau of Pharmaceutical Sciences TPD

Health Canada

Dr. Jan Welink.

Senior Pharmacokineticist

Dutch Evaluation Board, The Netherlands

Shereeni Veerasingham, MBBS, PhD

Assessment Officer

Division of Biopharmaceutics Evaluation 2

Bureau of Pharmaceutical Sciences