Since its inception nearly 10 years ago, the Middle East Regulatory Conference has grown to become an important forum for discussion of matters related to the provision of healthcare in the region, with a specific focus on issues around the evaluation and supervision of medicines for human use. The conference offers the opportunity for key stakeholders active in the region, including representatives from ministries of health, local and multinational pharmaceutical companies, to meet to exchange views, discuss topics of interest and identify actions to increase patient access to new and improved medicines and therapies.

Key Issues
•Updates on global regulatory developments.
•EU New Medicines Legislation and how it will impact regulatory requirements.
•Clinical trial data availability Middle East Regional Regulatory Developments (including GCC-DR update).
•Importance of product lifecycle management.
•Procedural aspects of variations systems.
•Procedural aspects of urgent/non-urgent labelling changes.
•Pharmacovigilance - mechanisms for gathering and disseminating data.
•Elements of quality review in the Middle East.