GCC Pharma Regulatory Summit
Regulation Pharmacovigilance Market Access


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PRA is launching the GCC Pharma Regulatory Summit that will take place on the 10-11th of April 2017.
The summit also includes:
9th of April: Master class on e-CTD
12-13th of April: Pharmacovigilance training

The summit will give a full picture of the specifics of regulating the pharma market in the GCC region: UAE, Kingdom of Saudi Arabia, Bahrain, Kuwait, Qatar and Oman.

The event will dissect the GCC pharma sector’ existing regulatory framework, and will create a platform for information to be exchanged between legislators, company directors and regulatory and compliance managers.

The Summit will feature discussions between professionals and regulators on issues which the industry faces every day: timely reaction to legislative amendments, drug registration, introduction and application of new requirements and concepts.

During this event the participants will discuss the most effective ways of entering new and safe drugs on to the market, and will learn from the experience of other professionals who have successfully carried out a variety of legislative and compliance tasks.

Why attend GCC Pharma Regulatory Summit?

• Hot topics including regulatory affairs, regulatory compliance, registration, drug registration, biosimilars, pricing, localisation, safety, quality control, market access and pharmacovigilance

• Special topic: Manufacturing in the GCC

Different speaking formats: Industry leaders debates, interviews, analyst address, spotlight presentations, panels and Q&As.

Over two days, 40+ speakers will analyse and discuss the most important tasks facing their sectors today, and will address specific topics relating to the latest regulatory initiatives, and specifics of the regulatory affairs market in the GCC region

This Summit is the only strategic meeting-place for regulatory affairs, legal and compliance managers, with speakers and attendees from its most influential companies, as well as GCC and international authorities. Delegates will gain both market and commercial information in addition to regulatory updates, giving you the opportunity to take away invaluable strategic knowledge.

MEET REGULATORS to learn about the latest changes to legislation. Confirmed speakers include:
Dr Amin Hussain Al Amiri, Assistant Undersecretary of Public Health Policy & Licensing Sector, Ministry of Health and Prevention UAE
Dr Mariam Al Jalahma, CEO, National Health Regulatory Authority (NHRA) Bahrain
Ph. Ahmed Al Harbi, Director of Drug Control, DGPA&DC, Ministry of Health in Oman
Nisreen Nassr, Section Head of Registration of Human Medicines, Ministry of Health Oman
Dr. Ola Ghaleb Al Ahdab, Pharmaceutical Advisor CPD-Pharma Program Manager, Drug Department Public Health Policy & Licensing Sector, UAE MOHAP
Ihab Attia, Regulatory Affairs Director - Middle East Affiliate (MEA), Eli Lilly (Suisse) S.A.; RAWG (Regulatory Affairs Working Group) Gulf Chair Person
Mona Al Moussli, Regulatory Affairs Consultant, Professional Regulatory Affairs Consultancy (PRA), Dubai, UAE
Dr Jorge Mestre-Ferrandiz, Independent Economics Consultant, Spain
Adel Alzahrani, Senior Pharmacist, Pricing and Pharmacoeconomics, SFDA
Dalia Fouad, Country Regulatory Head, Sanofi

We are receiving new speaker confirmations every day – please bookmark the event website www.pramagcc.com to stay up-to-date.mwan


Profesionals Regulatory Affairs