7th Middle East Regulatory Conference (MERC)
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7th Middle East Regulatory Conference (MERC)
The conference was organized by the Drug Information Association. The program was the initiative of the Middle East Regulatory Network of the European Federation of Pharmaceutical Industry Association. Program advisors from the Middle East health authorities also contributed to its development. The key topics were changing global regulatory environment; European New Medicines Legislation; Singapore regulatory review model; Good Manufacturing Practice (GMP) and Pharmaceutical Inspection Co-operation Scheme (PIC/S); Middle East regulatory environment (Good Review Practice, Gulf Central Committee on Drug Registration, Saudi Food and Drug Administration [SFDA], Iran); and clinical data disclosure and biotech products. Conference attendees included delegates from 11 Middle East regulatory authorities, faculty members from regulatory authorities (United Arab Emirates, Saudi Arabia, Iran, and Singapore), PIC/S, International Federation of Pharmaceutical Manufacturers Associations, Centre for Medicines Research International (CMR), and the pharmaceutical industry. The conference chairman was Professor Stuart Walker, CMR International Institute for Regulatory Science, and the keynote speaker was Professor Trevor Jones.
The 7th Middle East Regulatory Conference (MERC), hosted & the Ministry of Health, the United Arab Emirates, took place in Dubai on November 14-16, 2006. The conference organizers capture the kq proceedings and outcomes of the meeting, including details of the closed workshop held with Middle East regulators.
INTRODUCTORY REMARKS Professor Stuart Walker, Centre for Medicines Research International International Institute for Regulatory Science, United Kingdom. Professor Walker welcomed everyone to the conference and highlighted current challenges and key issues in global drug development and regulatory review. He listed the main challenges as cost of development, pricing pressures, patent litigation, parallel imports, animal extremists, and regulatory stringency. Although the pipeline size is increasing, the development time is not reducing and research and development (R&D) costs are continuing to rise. The regulatory environment has become increasingly challenging with respect to safety issues and postmarketing commitments. Key issues in the changing regulatory environment are development and assessment of biotech products, pricing and reimbursement, Certificate of Pharmaceutical Products (CPP) implications, Good Manufacturing Practice (GMP) issues, including inspection and sampling, regional opportunities, and clinical data disclosure. The final part of the presentation covered opportunities for improving patients’ access to medicines in the Middle East. Currently regula-
Drug Information Journal. Vd.41, from pp. dij.sagepub.com 41.3-421,2007 0092-8615/2007 Downloaded at RUTGERS UNIV on June 4, 2015 Printed in the USA. All rights racrved. Copyright 0 2007 Drug Information Association. Inc.
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7th Middle East Regulatory Conference
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