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REGULATORY TRACK - Session 2: Regulatory Convergence, Collaboration and Reliance - Part 2, a Regional Perspective
Session Chair(s)
Maja Lovrek Romcevic, MPharm
Head of Medicines Authorisation Division, Agency for Medicinal Products and Medical Devices, Croatia
Amira Younes
Director- Europe, Middle East & Africa (EMEA), Global Regulatory Policy, MSD, United Arab Emirates
Following the previous session, we will discuss how convergence, harmonisation & collaboration based on Reliance and Trust are the way forward, and are key enablers to manage resource constraint, capability building and remove access barriers. Continuing to use efficient reliance implementation on the national level, as well as advocating for improvements and for broadening the scope of reliance procedures beyond initial MAA to the whole lifecycle of the product is highly recommended to facilitate access of medicines. Session II will explore numerous examples where regulatory reliance pathways, work sharing and recognition have been established and/or are further developed by regulators in the region.
This session will include:
- Practical experiences by regulators from the region, reflecting the regional perspective.
- Industry perspective on reliance, collaboration and convergence, sharing EFPIA joint position paper.
- Industry leveraging case studies showing New Indications, PAC through New indications (multi-country packs).
- Panel Discussion with the speakers from both REG.1 and REG.2 sessions.
Speaker(s)
Twinning - an EU instrument for cooperation between EU Member States and beneficiary countries (Croatian support to Montenegro example)
Lina Cacic, MSc
Principal Advisor for Regulatory Affairs, Croatian Agency For Medicinal Products and Medical Devices (HALMED), Croatia
Montenegro’s Experience with Reliance
Lidija Cizmovic
Head of Centre for marketing and safe use of medicines, Institute for Medicines and Medical Devices, Montenegro
Bosnia & Herzegovina’s Experience with Reliance
Biljana Tubic, DRSc
Deputy Agency Director for the Department for Medicinal Products for Human Use, Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Path Forward to Optimise Post-Approval Change Management Worldwide – the Joint Industry Perspective
Susanne Ausborn, PhD
Global Head International Regulatory Policy, Roche, Switzerland
Panel Discussion, with the additional participation of:
Ranela Ceci, PhD
Specialist, Marketing Authorization and Regulatory Affairs Department, National Agency For Medicinal Products and Medical Devices (AKBPM), Albania
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