Human Medicines Symposium 2017


A wide range of speakers from the MHRA, other European national agencies, the EMA, the European Commission, plus industry will provide a broad range of insight and discussion into the world of regulatory affairs on matters affecting us today and in the future. Discuss and understand proposed regulations and the wider issues affecting your regulatory role.

Book your ticket

Prices:

Member: £1,925 + VAT
Non member: £2,195 + VAT

Discount options:

25% discount for regulatory or government agencies or academic institutions.

Bulk booking deals available.

  Monday, 2 October
11.30–12.30

Registration, exhibition and refreshments

12.30

Welcome to 2017 Symposium

12.40

TOPRA Annual Lecture 2017


13.15–14.45

Session 1: Delivering the European Network Strategy – priorities for 2018

Two years ago, the Heads of Medicines Agencies and European Medicines Agency adopted their high-level strategy to 2020. This ambitious strategy set out plans and priorities for the years ahead. What progress has been made so far? What are the network’s priorities as we move into 2018 and beyond?

Leader:

Speakers:


14.45 Break
15.15–16.45

Session 2: Ensuring timely regulatory approval of medicines and access for patients

Ensuring timely decision making and access for patients is a global priority, especially in diseases of high unmet medical need. A push to optimise high-quality evidence generation and increase stakeholder dialogue has been put forward by regulators, health technology assessment bodies and other decision makers, in an effort to facilitate that patient needs are addressed through optimal outcomes and that predictability is optimised during an increasingly evidence-based drug development. The aim of this session is to present stakeholders’ views on current and future initiatives to ensure access for patients through collaboration and tools, as well as to reflect on challenges for R&D activities.

Leader:

Speakers:

  • Michael Berntgen, Head of Product Development Scientific Support Department, EMA, UK
  • Emily Crowe, Technical Adviser, National Institute for Health and Care Excellence (NICE), UK
  • Simon Bennett, Director, Global Regulatory Policy EU Lead and GEMS Interim Lead, Biogen, UK

16.45 Tea / Coffee break
17.15–18.45

Session 3: Regulatory collaborations on the world stage

The EMA, US FDA and Japanese PMDA are working together to deliver better regulatory processes and healthcare – and the impact of the Bill & Melinda Gates Foundation work.

Leader:

Speakers:


18.45 Symposium networking dinner
  • Michael Berntgen, Head of Product Development Scientific Support Department, EMA, UK
  • Emily Crowe, Technical Adviser, National Institute for Health and Care Excellence (NICE), UK
  • Simon Bennett, Director, Global Regulatory Policy EU Lead and GEMS Interim Lead, Biogen, UK
  • No content found

    No content found

    No content found

    No content found

    Programme subject to change.