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
Pharma Manufacturers
- Indian – INR 16000
- International – USD 300
Solution Providers
- Indian – INR 24000
- International – USD 500
* Group booking discount for 2 is 10%, 3 -4 is 15% and for 5 and above is 25%
Speakers
Dr. Mansoor Khan
Regents Professor and Vice Dean, Presidential Impact Fellow, Rangel College of Pharmacy, Texas A&M University
Dr. Emilija Fredro-Kumbaradzi
Associate Director – Biowaivers & Biocorrelations and Stat.Support, Apotex
Dr. Tycho Heimbach
Director – Sterile & Specialty Products Group, Biopharmaceutics, Merck & Co., Inc., Rahway, NJ, USA
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
Board of Trustees Distinguished Professor of Pharmaceutics, Pfizer Distinguished Chair of Pharmaceutical Technology
Register Now
Phone
(+91) 88490 97588
contact@treffenmedia.com