With the ministry of health and family welfare making bioequivalence studies compulsory for all drugs on April 3 this year, the focus on patient safety and efficacy has improved greatly. This mandate in addition to being an accurate tool to test the quality of generics has also come at a precise time with the debate of prescription of generics medicines.
Bioequivalence and bioavailability studies in addition to ensuring efficacy of the drugs also helps in identifying the risks associated with the consumption of the drugs. With the US FDA, EMA, WHO and MSF not accepting drugs without the submission of BA/BE studies, it was a needed initiative to comply with global quality standards. A number of experts have been pushing for this mandate citing patient safety and quality assurance and if implemented properly promises to reduce the risks associated with consumption of generics.
US FDA and MHRA experts will be gathering on May 18 and 19, 2017 at Radisson Blu, Hyderabad, for the 'Biowaivers and Bioequivalence' workshop to further discuss the challenges associated with bioequivalence studies and its impact on approvals for regulated markets. Among the experts will be Dr. Muhaned Al-Hindawi, who has reviewed many bioequivalence studies as a senior pharmaceutical assessor, MHRA for over 10 years and is a well renowned authority on EU quality compliance with a rich technical experience spanning over 30 years.
Sharing insights on the regulatory expectations of the USF DA will be Dr Mansoor A. Khan who has served FDA for over 11 years as the Director of Product Quality Research and a Senior Biomedical Research Scientist (SBRS) at CDER, where he helped develop regulatory policies for reviews and compliance, and led CMC review and research teams on drug delivery systems, product stability, biotech products, and biopharmaceutics. As SBRS scientist, he also served as the science policy advisor to CDER Center Director where he helped resolve complex issues of drug reviews and FDA compliance with science.
On the second day gracing the occasion will be Dr Ajaz Hussain who is a globally recognized leader in pharmaceutical quality and has been one of the most influential ‘Medicine Maker’ for two years in a row. His contributions at FDA include the Biopharmaceutics Classification System (BCS) Guidance among other specific topics.
To discuss the Indian perspective and the practical challenges faced by Indian companies, Dr V Venkatesvarlu will be sharing his insights from his academic and industry experience.
For more details about the event , visit www.biowaivers-bioequivalence.com