WELCOME

If you are active in Pharma Regulatory Affairs, this is a must conference that provides a brand NEW platform that will allow you to access, participate and engage with senior GCC government regulators and industry professionals with a great lineup of international industry experts transferring valuable knowledge

Dubai, UAE

Habtoor Grand Resort

12-13 March

This year of course

50 Speakers

Best Experts.

300 Seats

Hurry up, register!

Program Highlights 2018

Regulatory
Updates

Get the latest GCC and International Pharma Regulatory Updates

Regulation of
Drug Counterfeit

GC1 & Pack serialization implementation

Pricing
Regulation

Pricing structure overview from across the globe and GCC

Manufacturing in
the GCC

Regulatory requirements. Validation

Clinical
Trials

Implications for Clinical investigation in Gulf countries

Government &
International Speakers

Meet Government Authority decision makers and Industry professionals

Biosimilars
regulation

Updating requirements and assessments

New Pharmacovigilance
procedures

Implication of implementing guideline on GVP for Arab countries

Pharmacovigilance Training
12-13 March 2018

This training workshop is intended for Qualified persons for pharmacovigilance and national PV officers who would like to improve their daily practice and better understand regulatory expectations and practical implications. The workshop is led by an expert instructor who has been a EU/EEA QPPV for 17 years and helped establish the EU QPPV Forum with which he is still involved. Together with two experts from MOHAP UAE and CAPA (Ministry of Health and Population Egypt), they aim to interactively help you better understand the daily challenges you face and hear about solutions from others in similar situations.

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eCTD TRAINING
27 & 28 September 2017

This hands-on training given by EXTEDOs Regulatory Experts will be based around eCTD, the format itself and the relevant surrounded common business processes. This time the training will consist from 2 parts:

27th of September – Level 1. You will gain basic understanding of what eCTD is about and the practical experience on how to build and compile a valid submission.

28th of September – Level 2 is an advanced level where we will analyse the eCTD format in detail, check the validation rules, create our own test submissions, including errors and how to validate them.
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Supporting organisations and partners

Speakers 2018

Photo Gallery 2017


Feed back from our 2017 attendees

Get Involved

There are a number of ways to participate in the conference: If you an established provider in the pharmaceutical industry and would like to showcase yourself Become a partner

If you are expert in the Pharma Regulatory Affairs field with a great story to tell then let us know and join the speakers panel Become a speaker

If you would like to attend as a visitor register here now Interested in attending

Why Attend

Meet New Faces

MORE THAN 150 PARTICIPANTS, among them your peers, advisors, clients and potential business partners

Get Inspired

A TWO-DAY PROGRAMME, filled with analysis, strategic ideas and exclusive new information from top speakers

Informative Platform

INTERACTIVE FORMATS, including industry leaders debates, interviews, discussions, analyses, Q&A, round tables and master-classes

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