Summit Schedule

Agenda | Pharma Regulatory Affairs
This session will feature representatives of the GCC region’s major regulatory bodies who will speak about their national registration procedure, changes in the regulation and what they will be focusing on in 2019. This year we have also asked all speakers to include in their presentation the latest status and updates of “Fast Track” approvals and priority reviews; real timeline for the fast track registration and what are the benefits seen so far.
  • Comparisons between European, USA and GCC regulatory requirements and expectations
  •  Brexit – how it will impact the GCC region? Implications for Regulatory Affairs professionals and the Pharmaceutical industry in Europe and the global market
  • Regulatory environment in these countries
  • Latest regulatory changes and updates for product registration
  • Key challenges with submissions, timelines and best practices
  •  How these countries regulatory requirements compare to the GCC region
Despite the country’s small size, Singapore boasts a highly-developed economy and serves as an Asian hub for numerous medical companies. In total, Singapore’s medical device and pharmaceutical markets are estimated at over $800 million. We will invite the representative of The Health Sciences Authority (HSA) to give a presentation about the Pharma market and its regulation in the country and what they do differently in comparison with the GCC region. Special focus on IP.
IP is a pharmaceuticals company’s most valuable resource, and its protection is a key to its future success. Pharmaceuticals companies face the daily challenge of creating value through the exploitation of IP rights, but avoiding considerable reputational harm. An international Pharma IP legal expert will share their knowledge in this field and give an overview of the best strategies to keep the balance between opposing forces of innovation through protection of IP rights, versus the provision of affordable drugs for the developing world.
We will close day One of the Summit with an interactive session discussion. The audience will be divided into 10 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 its neighbours
  • Group 1: UAE
  • Group 2: Kuwait
  • Group 3: Oman
  • Group 4: Saudi Arabia
  • Group 5 Bahrain
  • Group 6: Egypt
  • Group 7: Iran
  • Group 8: Lebanon
  • Group 9: Jordan
  • Group 10: Singapore
For this session we have invited an expert from London School of Economics (LSE) and Political Science who will share with the audience his study and knowledge on Pricing and Pharmacoeconomics
  • When is the serialisation deadline in the region (by country)?
  • What is the serialisation requirements in comparison with rest of the globe
  • Challenges that industry is facing with meeting the requirements and how these can be overcome
  • What are the government expectations?
  • Biosimilars regulation in Europe & USA.  Global Development to meet all Regulators expectations
  • MENA vision on Biosimilars Regulation. Where are we now
  • Switching, Substitution and Interchangeability
  • Biologic manufacturing & Quality considerations
  • Case Study: Biosimilars Access Barriers and Solutions in Jordan
LCM is currently playing a big part in pharma companies strategy trying to increase margins and keep a competitive edge. This session identifies some key business metrics that benchmark a company’s performance and key strategic business processes required to improve product performance through a LCM business transformation approach and the regulatory compliance that goes with it.  
  • Overview of Current Pharmaceutical environment in the GCC Region
  • Key challenges in the LCM landscape
  • Focus on Regulatory & Legal Strategies
  • Case Studies and Examples:
    • Successful LCM strategies employed by Big Pharma
    • Unsuccessful implementation of LVM strategies
  • Recommendation for the GCC region
The digital revolution is well under way for Pharma. The GCC region is particularly affected as Governments announced strategies with Innovation & Digitalisation at its heart and seen as the key for regional development. The Critical question now for Pharmaceutical companies in the MENA region is how to timely adopt digital solutions, build innovative business models, invest in new capabilities and transform organisational culture.   For this session we will additionally invite companies to present their success stories of partnerships with pharma companies on digitalisation. Each company will have 10 minutes to present their case study  
  • Case Study 1: Digital Technology for distributors and the pharmacy chains
  • Case Study 2: e-commerce in the pharmaceutical market. Online sales of pharmaceutical drugs: is there a future in MENA? What challenges will companies face selling pharmaceutical drugs online? How to ensure safety and security?
  • Case Study 3: Telemedicine: Opportunities for Pharma
  • Case Study 4:  New ways of Medicine delivery: Do we still need pharmacies?
Implementation of risk minimization measures on local level and their effectiveness. Additional Risk Minimization Measures, from planning to execution.
  • Key presentation from healthcare professions: Detection and reporting of AE and other safety information; how can industry and regulators help? What are the main issues that hospitals are facing with the reporting. Why the reporting is so low. (15 minutes)
  • Key presentation from the Industry: How industry & regulator can encourage AE reporting from HCPs and effective engagement mechanisms? Is the hospital reporting system is recognised by industry? The quality of the reporting: is the minimum enough? What is the right concept minimum or maximum? (15 minutes)
  • Round tables discussion with feedback on Reporting system and how it can be improved. What are the industry expectations from Hospitals &  that of Hospitals  from  Pharma?