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.
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
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
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.
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