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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 (Hrvatska)
Amira Deia Younes
Director, Eastern Europe, Middle East & Africa (EEMEA) 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
Croatian Agency For Medicinal Products and Medical Devices (HALMED), Croatia (Hrvatska)
Principal Advisor for Regulatory Affairs
Montenegro’s Experience with Reliance
Lidija Cizmovic
Institute for Medicines and Medical Devices, Montenegro
Head of Centre for marketing and safe use of medicines
Bosnia & Herzegovina’s Experience with Reliance
Biljana Tubic, DrSc
Agency for Medicinal Products and Medical Devices (ALMBiH), Bosnia and Herzegovina
Deputy Agency Director for the Department for Medicinal Products for Human Use
Path Forward to Optimise Post-Approval Change Management Worldwide – the Joint Industry Perspective
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Panel Discussion, with the additional participation of:
Ranela Ceci, PhD
National Agency For Medicinal Products and Medical Devices (AKBPM), Albania
Specialist, Marketing Authorization and Regulatory Affairs Department
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