6th Middle East Regulatory Conference (MERC): Key Proceedings
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Brian Hewitt, CChem, PhD,MTOPRA MRSC, Middle East Regulatory Network Chair, Unitedand Kingdom Pfirer, Afschin KhodaverdiAfaghi, MSc Middle East Regulatory Network Co-Chair, and Schering AG, Germany Elaine Whiting, BSc, MTOPRA Middle East Regulatory Network Secretariat, and AstraZeneca UK Ltd, United Kingdom Sheherazad Aftabroushad, PharmD, PkD Eli Lilly, Switzerland Kerstin Ahrendt-Solter, MA Chiron Vaccines, Italy Nadine Otir, PharmD Sanofi-Aventis, France Olivier Moreau, MSc Novartis, Switzerland
Key Words Middle East; Regulatory authorities; Regulatory environment; Pharmaceuticals Correspondence Address Elaine Whiting, A Z International Regulatory Affairs, Silk Court, Macclesfield, Cheshire S K I 0 Z N A , United Kingdom (e-mail: Elaine.Whiting@astrazeneca .corn).
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6th Middle East Regulatory Conference (MERC): Key Proceedings The 6th Middle East Regulatory Conference (MERC), hosted €ythe Ministry of Health of the United Amb Emimtes, took place in Dubai on September 28-30,2004. This article presents the key proceedings and outcomes of the conference, including details of the closed workshop held with Middle East regulators. The conference was organized by the Drug lnformation Association. The program was the initiative of the Middle East Regulatory Network of the European Federation of Pharmaceutical lndustry Association. Program advisors from Middle East health authorities also contributed to its development. The key topics were: best practice from the global regulatory environment, 'Total Quali@" the rde of intellectual
WELCOME ADDRESS Dr. Easa A1 Mansouri, Director,Drug Control Department, Ministry of Health, United Arab Emirates. Dr. A1 Mansoori opened the conference by noting the development of pharmaceutical regulation in the Middle East since the first MERC in 1996. He stated that against a background of global changes, the harmonization among Arab states has progressed significantly. In addition, there are challenges with changing technology and complex pharmaceutical products. Despite all of these changes and challenges, the common goal has remained the same, that is, to make safe and effective medicines available to patients as quickly as possible. Dr. Al Mansoori expressed the view that good communication, mutual respect, and understanding will help achieve this goal. He noted that the MERC series has clearly contributed to the common goal.
property rightddata protection, Gulf Central Committee for Drug Registration (GCC-DR) update, the International Conference on Harmonisation (KH) Global Cooperation Group, and counterfeitmedicines. Conference attendees included delegates from 12 Middle East regulatory authorities, faculty members from regulatory authorities (United Arab Emirates, Saudi Arabia, GCCDR and Norway), the World Health Organisation, the Centre for Medicines Research lnternational, and the pharmaceuticalindustry. The conference chairman was Professor Stuart Walker (Centre for Medicines Research lnternational Institute for Regulatory Science, United Kingdom).
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