Mohammed R. Khan
Keynote: Pharmaceut Reg Affairs
Going back in times, patented medicines were commonplace in the United States. Cure-alls such as Snake oil were abundantly used, while ova of Tape Worm were packaged and sold for the treatment of obesity! In contrast, today?s pharma industry is believed to be based on sound ethical foundations, and is expected to deliver quality offerings to the consumer that are safe and effective when used appropriately. And in common with all successful businesses, pharmaceutical establishments are also expected to keep the shareholders satisfied by providing adequate return on investment, while also remaining competitive in the marketplace. The emerging picture however is not that rosy. Without distinction of size and origin, the industry is displaying a pattern that poses great cause for concern. Print media abounds with reports of Non-Compliance of GMP standards, falsification of data and test results, false claims related to blockbuster drugs, paying billions in fines to settle bribery, fraud, kickbacks, and improper marketing allegations. These are not isolated incidences but a sort of emerging trend that appears to suggest gradual degradation of the quality culture and marketing ethics. It is indeed a wakeup call!
Mohammed R. Khan is a Quality Management Consultant and Principal, Synergex Consulting, Canada. He has earlier served as Director QA/QC and Regulatory Compliance with DuPont Pharmaceuticals Canada, and also as a Director of the Pharmaceutical Manufacturers Association of Canada, Plant Operations Section. As an active member of the Drug Information Association, he has served on the DIA Advisory Council of North America, Chaired the DIA Canadian Programming Steering Committee, and served as Program Coordinator, Program Committee Member, Session Chair and Speaker at a vast number of the DIA events in the US, Canada, Europe and South Asia. He is a recipient of the DIA Outstanding Service Award. He has also served as a Presenter for the PDA in Europe and Japan, IQPC in the US, PSG Canada, and IPC India.
Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report