Human Medicines programme 2017

MONDAY, 2 OCTOBER

Registration, exhibition and refreshments

11.30–12.30


Welcome to 2017 Symposium

Bob Clay – TOPRA President, UK; Dr Ian Hudson – CEO, MHRA, UK.

12.30


TOPRA Annual Lecture 2017

Dr Murray M. Lumpkin – Integrated Development (Regulatory Affairs), Lead for Global Regulatory Systems Initiatives, Global Health | Integrated Development, US.

Sharon Gorman – Pfizer, Chair of symposium working party.

12.40


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?

 

Chair: Dr Ian Hudson – CEO, MHRA, UK

 

 

Introduction: Part-way through the ambitious Multi Annual Work Plan (MAWP) the landscape has changed, resulting in a refocus on our priorities for the next year.
Ian Hudson – CEO, MHRA, UK

13.15

HMA MAWP: Achievements and priorities for 2018
Kristin Raudsepp – Director General State Agency of Medicines, Estonia


13.20


EMA MAWP: Achievements and priorities for 2018
Agnès Saint-Raymond – Head of International Affairs, EMA, UK


13.45


Panel discussion moderated by chair with today’s speakers plus invited guest Christer Backman – Senior expert International Relations, Office of the Director General, MPA, Sweden and Shaun Stapleton, Reneuron – this is your opportunity to explore the topic more fully.


14.10



Break

14.45


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.

 

Chair: João Duarte – Associate Director, Europe Regulatory Policy & Intelligence, Takeda


 


Introduction

15.15

How is the EMA supporting drug development to ensure it is geared towards addressing unmet medical needs?
Michael Berntgen – Head of Product Development Scientific Support Department, EMA

  • The experience with early access tools (eg, CMA) and platforms such as PRIME
  • Perspectives on the need to ensure a holistic view on development programmes
  • Enhanced collaboration with other decision-makers to facilitate the shaping of evidence generation and review.

15.20


HTA bodies as partners in patient access: how to ensure alignment in evidence expectations
Emily Crowe – Technical Adviser, NICE Scientific Advice Program, National Institute for Health and Care Excellence (NICE), UK

  • Health technology assessment (HTA) bodies are increasing advice provision to drug developers: already a routine partner?
  • Areas of uncertainty identified at the HTA appraisal that could have benefited from earlier stakeholder engagement
  • How is European collaboration with regulators seen in the near future (eg, EUnetHTA)?
  • Current experience with EAMS scheme in the UK on access.

15.40


Industry views on current challenges and opportunities on timely approval and access to patients
Simon Bennett – Director, Global Regulatory Policy EU Lead and GEMS Interim Lead, Biogen, UK

  • What is the industry view on the latest developments in the EU (from national schemes to SMART EC discussions, etc)?
  • Do we have good examples on how industries can fully align their development dialogue with authorities (ie, case studies with PRIME, Sci–HTA advice, etc)?
  • Which challenges and opportunities can schemes such as these bring?

16.00


Panel discussion with this session’s speakers moderated by chair with above speakers and invited panellist Jordi Llinares, Head of Scientific and Regulatory Management, EMA

16.20


Tea / Coffee break

16.45


Session 3: Regulatory collaborations on the world stage

Insights on how the EMA, US FDA and Japanese PMDA are working together to deliver better regulatory processes and healthcare, and the impact of initiatives supported by the Bill & Melinda Gates Foundation.

 

Chair: Carlos Langezaal – Director, Global Regulatory Affairs, Eisai Inc, US


 


Introduction


17.15


The Office of International Programs within the Japanese PMDA and the collaborations between the PMDA and EMA and other Asian health authorities
Kondo Hideyuki – MHLW/PMDA Liaison Official, International Affairs at the EMA, Japan

  • Update on the Office of International Programs of the PMDA
  • Collaborations between the PMDA and EMA
  • Collaborations between the PMDA and other Asian Health Authorities

17.20


Five years experience as EMA liaison official to the US FDA
Sabine Haubenreisser – Principal Scientific Administrator International Affairs, EMA

  • Progress made in the various areas of cooperation between the EMA and US FDA, including creation of new cluster meetings, GMP inspections, parallel scientific advice

17.40


Introducing the ICMRA (International Coalition of Medicines Regulatory Authorities)
Christer Backman - senior expert, International Relations, Office of the Director General, MPA, Sweden


18.00


Panel discussion with this session’s speakers and invited guests Agnès Saint-Raymond – Head of International Affairs, EMA and Dr Murray M. Lumpkin, Deputy Director – Integrated Development, (Lead for Global Regulatory Systems Initiatives), Bill & Melinda Gates Foundation, US

18.20


Symposium Networking Dinner 'London on a Plate'

Supported by Pharmalex

Meet your colleagues for drinks and dinner with a UK theme in the Exhibition Hall

18.45

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Programme subject to change.