· Two-day event a valuable knowledge and growth opportunity for pharma firms

· 50 experts will address conference, held 15-16 October at Cairo Marriott

Cairo - Egypt - Pharmaceutical regulations and industry growth in the Gulf Co-operation Council (GCC) States as well as in the wider Middle East & Africa region will be on focus at the ‘Egypt Pharma Regulatory Conference’ to be held at the Cairo Marriott Hotel, 15-16 October 2017.

The two-day conference, organised by the UAE-based Professional Regulatory Affairs with the support of regulators, advocacy groups and pharmaceutical companies, is designed to enable industry stakeholders learn about the opportunities, regulations and challenges in the fast-growing regional economies.

More than 50 speakers from the various disciplines of pharma trade and regulation will address the conference, which is expected to attract over 150 participants. Participants will be guided through the pharmaceutical industry landscape in the GCC, Middle East & Africa markets with emphasis on the business potential, export regulations and procedures, local manufacturing industry, pricing mechanisms and pharmacovigilance procedures.

Dr Najiba Al Shezawy, General Manager of Professionals Regulatory Affairs, said: “The Egypt Pharma Regulatory Conference is a must-attend event for any company looking to expand or enhance their pharmaceutical business in the GCC, Middle East & Africa markets. The event is set against the backdrop of the Egyptian pharmaceuticals sector and the growth projected in GCC pharmaceuticals, to help participants understand, evaluate and enter the regional market.”

Increasing healthcare budget in the GCC and corresponding allocation for pharmaceuticals, along with rise in local production, make it necessary for the industry and professionals to remain updated on the market dynamics. Local production currently account for up to 25% of the medicines sold in some GCC States and region-wide, pharmaceutical sales is growing at a compounded annual growth rate (CAGR) of 6-8% towards reaching US$11.6 billion by 2020.

UAE, currently the second biggest healthcare market in the GCC, is set to have 30 pharmaceutical production units by 2020, by which its healthcare sector is projected to cross AED 71 billion.

“According to the UAE Ministry of Health, the country is close to being self-sufficient in the production of generic drugs and the goal is to make the UAE an international hub for pharmaceutical production. The ‘Egypt Pharma Regulatory Conference’ will provide the local industry and professionals in the demand as well as supply side with the knowledge and updates required to be in the crest of this new growth wave,” added Dr Al Shezawy.

Regulators, industry professionals and experts from Egypt, GCC and Africa will share their knowledge, updates, analysis and forecast on the regional pharmaceutical sector at the conference. Representatives from a number of pharmaceutical companies have also been invited to share their experiences in the region, particularly in regulatory compliance and in working with national authorities in promoting competitive legislation.

Dr. Mona Al Moussli, CEO of Professionals Regulatory Affairs, said the conference agenda reflects the state of the industry and its future direction. “Leading Egyptian and international experts have also provided their inputs to the conference agenda. By the end of the conference participants will know what they need to be aware of and how to identify the right contacts in order to make the best use of the opportunities existing and emerging in the GCC and Africa markets,” added Dr Al Moussli.

The opening session of the first day of the conference will review the prevailing and anticipated regulatory situation in the Egyptian market with emphasis on drug registration and approval, pricing, drug supply situation, and new regulations. It will be followed by presentations on export registration and related regulations, opportunities and business potential in GCC & Africa. The opening will be held under the patronage of the Egyptian Pharmaceutical Industry Chamber.

Representatives of major regulatory bodies and pharmaceutical experts will analyse the main questions relating to drug registration procedures in the GCC in the second session of the day. It will be followed by presentations on the regulatory landscape in North African countries and the pricing mechanism in GCC States.

Industry champions will discuss market access challenges and drug regulation in Egypt in the opening session of the first day, following which the challenges facing local manufacturers in GCC & North Africa will also be brought under the spotlight. Experts will share perspectives on GCI & Pack Serialization Implementation, new pharmacovigilance procedures in the regional markets under review and their impact on drug safety, and bioequivalence, during the rest of the day.

Speakers will also provide updates on common technical document (CTD) submission and the latest eCTD on the second day. A post-conference workshop has also been scheduled for the 17th of October 2017 to enable participants to compile, publish and validate a fool-proof eCTD submission in the regional markets concerned.

Speakers confirmed for the conference include: Dr Mariam Al Jalahma, CEO, National Health Regulatory Authority, Bahrain; Ramy S Behbehani, Medicines & Drug Laboratory Superintendent at Kuwait Drug & Food Control Administration – MOH; Mohammed A. Alageel, Head of GMA Department at Saudi FDA; Ph. Mohammed Hamdan Al Rubaie, Director General of Pharmaceutical Affairs & Drug Control, MOH – Sultanate of Oman; Dr. El Zain Al Fahal, Secretary General, National Medicines and Poisons Board -Sudan (NMPB -Sudan); Dr. Yacine Sellam, Assistant General Manager - Business Development, Institute Pasteur of Algeria, and Hadir Rostom, Head of the Egyptian Pharmaceutical Vigilance Centre (EPVC).

Major supporters to the conference include Janssen Pharmaceuticals, Extedo eRegulatory Affairs, Lorenz Life Sciences Group, Mesned Pharma Consult Centre (MPCC), and Mwan Mobile.

For more information about the conference, contact: Ayat Tareq    ayat@pra-me.com  

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© Press Release 2017