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5th Annual Biowiavers and Bioequivalence Workshop

25 August 2022
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About the workshop

5th Annual Biowiavers and Bioequivalence Workshop

With every development in the ICH M9 Biopharmaceutics Classification System Based Biowaivers Guidance, the FDA requirements for biowaivers are becoming clearer and concrete. With the increase in demand of medicines post pandemic, speedier approvals and manufacturing have become the need of the hour for both regulators and the pharma industry.

Complex generics and products though extremely high in demand and crucial, need a lot of time for development which add up to the costs. Biowaivers can help to significantly save time and costs and lead to speedier approvals and reduce the need for in vivo bioequivalence studies.

With leading experts and case studies, Treffen Media, brings you the “5th Annual Biowiavers and Bioequivalence Workshop“, to help you harness the potential of biowaivers to swiftly and safely bring complex products to patients.

Pricing

* Group booking discount for 2 is 10%, 3 -4 is 15% and for 5 and above is 25%

Speakers
Dr. Mansoor Khan

Dr. Mansoor Khan

Regents Professor and Vice Dean, Presidential Impact Fellow, Rangel College of Pharmacy, Texas A&M University

Dr. Emilija Fredro-Kumbaradzi

Dr. Emilija Fredro-Kumbaradzi

Associate Director – Biowaivers & Biocorrelations and Stat.Support, Apotex

Dr. Tycho Heimbach

Dr. Tycho Heimbach

Director – Sterile & Specialty Products Group, Biopharmaceutics, Merck & Co., Inc., Rahway, NJ, USA

Prof. Dr. Marival Bermejo

Prof. Dr. Marival Bermejo

External assessor of the EMA (European Medicines Agency) and Spanish Agency of Medicines (AEMPS) and Full Professor at the University Miguel Hernández of Elche-Alicante (Spain)

Prof. Dr. Diane J. Burgess

Prof. Dr. Diane J. Burgess

Board of Trustees Distinguished Professor of Pharmaceutics, Pfizer Distinguished Chair of Pharmaceutical Technology

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Phone

(+91) 88490 97588

Email

contact@treffenmedia.com