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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Session 7: Convergence & Reliance

Session Chair(s)

Susanne  Ausborn, PhD

Susanne Ausborn, PhD

  • Global Head International Regulatory Policy
  • F. Hoffmann-La Roche, Switzerland
Frank  Montgomery, PhD

Frank Montgomery, PhD

  • Global Head Regulatory CMC, GRAPSQA
  • AstraZeneca, United Kingdom

This Workshop will bring together regulators from different national/regional/global bodies and industry to discuss ongoing and future efforts to drive regional and global regulatory convergence. WHO has rolled out their Good Regulatory Practice and Good Reliance Practice guidelines and there are numerous examples around the world where regulatory reliance pathways, work-sharing and recognition have been established and/or are further developed. But more needs to be done to enable efficient and effective responses to public health emergencies and beyond.

Panellists from Regulatory Agencies and Industry representatives will share their experiences with different "working models" and reflect on the value of collaboration, what to take further from the learnings from the Pandemic and how to address existing barriers to ensure timely and continuous supply of medicines to patients in need around the globe.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Contribute to the establishment of a best practices framework for managing regulatory information and processes
  • Understand the benefit and structure of the RIM Reference Model and apply the structure, content, and nomenclature to RIM planning, design and implementation activities
  • Provide input to DIA RIM AI Use Cases

Speaker(s)

Samvel  Azatyan, MD, PhD

Reflections from WHO

Samvel Azatyan, MD, PhD

  • Team Lead, Regulatory Convergence and Networks (RCN/REG)
  • World Health Organization (WHO), Switzerland
Nawaf Matar Almutairi, MPharm

Reflections from Global Health Authorities on Convergence and Reliance

Nawaf Matar Almutairi, MPharm

  • Regulatory Affairs Expert
  • Saudi Food and Drug Authority , Saudi Arabia
Dmitriy  Rozdestvensky, MD, PhD

Dmitriy Rozdestvensky, MD, PhD

  • Head, Division for Coordination of Common Market for Drugs and Medical Devices F
  • Eurasian Economic Commission, Russian Federation
Raphael  Sanches Pereira

Reflections from Global Health Authorities on Convergence and Reliance

Raphael Sanches Pereira

  • Health and Regulation Expert / Office Manager
  • ANVISA, Brazil
Isabelle  Colmagne-Poulard, PharmD, MBA, MSc

Reflections from Industry on Convergence and Reliance

Isabelle Colmagne-Poulard, PharmD, MBA, MSc

  • Director, International Global Regulatory Affairs & Scientific Policy
  • Merck KGaA, Switzerland
Mark   Pellett

Recent Successes in the use of WHO Reliance processes in MA and PAC: AZ perspective

Mark Pellett

  • Director, Regulatory CMC,
  • AstraZeneca, United Kingdom