Summit Schedule

This session will feature representatives of the GCC region’s major regulatory bodies and pharmaceutical experts who will analyse regulatory changes during the past year and what are their future plans. Among the questions will include:

  • National registration procedures in the GCC region: country updates
  • Current status of the CGG Central registration procedure
  • GCC countries comparison: documentation requirements and submission timelines
  • Countries position on Pricing scheme, eCTD, labelling and serialisation
  • Review of the regulatory environment and best strategies of product registration in Turkey & Iran
  • Product registration and latest regulatory updates in Iran: Challenges and opportunities
  • Regulatory requirements and key challenges with submissions in Turkey
  • Case examples of successful product registration in Iran

Session featuring representatives of new entrants, established companies & government representatives

To attend this session we will invite MOHAP UAE, Ministry of Economy, Dubai Science park, Department of Economic Development and industry representatives. This session will focus mainly on two areas:

  • IP and Innovations
  • Challenges of IP protection in the GCC region

Global pharmaceutical companies lose an estimated $75 billion annually to counterfeit, grey market, and stolen product. Regulations will require pharma manufacturers to track and trace products across the supply chain. At the same time there is a bigger concern for the industry: costs and timeframe for implementation…and do all countries need it?

For this session we will invite local and international experts who will share their knowledge about the Serialisation, 2D barcodes: challenges benefits, costs, implementation and successful examples

We will close the day One of the Summit with an interactive session discussion.The audience will be divided into 7 groups. Each group will have a leader – an expert from an authority or Industry who will moderate the discussion and let the participants share their experience with product registration in GCC and the neighbours

  • Group 1: Oman
  • Group 2: Kuwait
  • Group 3: UAE
  • Group 4: Saudi Arabia
  • Group 5 Bahrain
  • Group 6: Iran
  • Group 7: Turkey
  • International principles and references on pricing and how they can apply in the GCC region
  • Special international expert who will share their experience on the pricing of medicines in their country
  • Industry perspective on Pharmacoeconomics in the GCC
  • Case Study: Pharmacoeconomics impact on Special products across GCC

Pharma industry questions and concerns when it comes to pricing: how the price is calculated, what is the new pricing quotation planned by MOHAP UAE, what the guidelines say. Difference in pricing methodology between countries? Pricing and reimbursement…

For this session we will invite representatives from Industry, government and experts who will give their opinion on these questions in a more informal discussion

The future of eCTD is one of the most important topics in the region today. Some MENA countries have implemented eCTD and some of them are only discussing CTD submissions. We will invite experts from different companies & authorities to cover the following questions:

  • Latest updates and changes for eSubmissions across the globe
  • Upcoming new regulation from 2019
  • Development of eCTD implementation in GCC. Are there plans to implement eCTD 4.0 in the GCC?
  • eCTD Timelines in the GCC
  • Legislation changes for eCTD implementation in the region
  • Expectations from the GCC central approach: Agency & Industry perspective
  • Harmonisation of the implementation of eCTD in GCC
  • Current legal aspects of biosimilars in the world
  • Regulatory guidelines and requirements for biosimilars in Europe
  • Regulatory expectations and plans in the GCC
  • Biosimilars prospective of local & international manufacturers
  • IP and patent protection considerations for biosimilars
  • What is the use and market uptake of biosimilars worldwide and in the GCC
  • Case Study: Successful access of the GCC markets: what is the best and most efficient strategy
  • Country-specific requirements in GCC for labelling and packaging
  • Labelling in GCC compared to international requirements
  • Impact on the industry entering the market
  • Successfully using GCC standard export packs and package inserts
  • Gulf countries labelling requirement
  • Country-specific requirements in GCC for labelling and packaging
  • Labelling in GCC compared to international requirements
  • Impact on the industry entering the market
  • Successfully using GCC standard export packs and package inserts
  • Gulf countries labelling requirement
  • Transition mapping message
  • Submission unit and submission
  • Two-way communication
  • Enhanced document life cycle
  • Document groups
  • Update Mode

Comming Soon

Comming Soon