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Drug Information Association to Host 10th Middle East Regulatory Conference


9/10/2013 9:00:21 AM

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Sept. 9, 2013 -- Muscat, Sultanate of Oman—DIA will host its 10th Middle East Regulatory Conference (MERC) from Sept. 24 to 25 at Shangri-La’s Barr Al Jissah Resort and Spa Al Bandar hotel in Muscat 113, Sultanate of Oman. The two-day event will bring together the Middle East Regulatory Network (MERN), an ad hoc regional network of the European Federation of Pharmaceutical Industries and Associations. The MERN works in partnership with regulatory authorities and the pharmaceutical industry in the Middle East to develop legislation and regulatory practices that enable patients to access high-quality medicines, including innovative products.

“We’re excited to provide this two-day event, which will offer invaluable information and knowledge to every attendee,” said Jytte Lyngvig, director of DIA Europe. “This meeting brings together thought leaders from across the globe who will provide timely and valuable information to key stakeholders in the region—including representatives from ministries of health, local and multinational pharmaceutical companies—who will meet to exchange views, discuss topics of interest and identify actions to increase patient access to new and improved medicines and therapies.”

MERC 2013 sessions include:

- Review Practices: Efficiencies & Timelines—Improving the registration process and reviewing the timelines of pharmaceutical and biological products.

- Regulatory/Industry Panel Interactive Session—Discussing challenges with a combined authority and industry panel to improve access to innovative medicine for patients.

- Pharmacovigilance: Monitoring and Evaluating the Safety Profile of Medicinal Products—Sharing recent developments in the European Union (EU), World Health Organization and Middle Eastern region as well as falsified medicines.

- The Concept of Biotech Medicine and Biosimilars—Updating biosimilar requirements and assessments.

- Global Health Economics and Market Access—Discussing faster and better accessibility to medicines for patients.

- Regulatory Life Cycle Management—Optimizing maintenance and product compliance.

- Regulatory Data Exclusivity and Patents—Educating stakeholders on the data protection landscape in the Middle East and what remains to be done.

- Code of Ethics and Promotion—Discussing the implementation in the EU and Middle Eastern regions and sharing regulators’ and the industry’s perspectives.

Ministry of Health speakers include:

- Professor Saleh A. Bawazir, vice president of drug affairs, Saudi Food and Drug Authority, Kingdom of Saudi Arabia

- Dr. Bahaa Eldin Fateha, chief executive, National Health Regulatory Authority, Kingdom of Bahrain

- Mr. Thomas Heynisch, deputy head of unit, Food and Healthcare Industries, Biotechnology, European Commission, Belgium

- Dr. Hayel Mohamad Obeidat, director general, Jordan Food and Drug Administration, Jordan

- Dr. Colette Raidy, head, Pharmaceutical Inspection Department, Ministry of Public Health, Lebanon

- Dr. Shahrokh Veisi, Biologics Department, Food and Drug Organization of Ministry of Health, Iran

- Dr. Christa Wirthumer-Hoche, member, CMDh, and deputy head, Austrian Medicines and Medical Devices Agency, Austria

To find out more about the event and to register, visit the website for DIA’s 10th MERC.

ABOUT DIA: DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and life cycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C.; and Latin America. Visit our website at www.diahome.org and follow DIA at: LinkedIn, Twitter, YouTube, Facebook, Flickr and Pinterest.

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