|All times BST (GMT+1)
|Delegates can choose from two options for the next session:
|10:15 – 11:45
HM4: Regulatory support to research and development
Leader and Chair: Jordi Llinares Garcia, Head of Research and Innovation, European Medicines Agency (EMA)
The translation of scientific advance into concrete deliverables that foster medicines development is a key focus of the EMA and its support to research and development activities. With that objective the EMA offers a number of platforms that can help research and development initiatives at different keeping in mind the need of catalyzing the integration of science and technology in medicines development. Support to innovation and development thought adequate contacts and discussion with developers includes biomarker’s qualification and generally the qualification of novel methodologies as well as other proposals that may serve patient’s needs such as repurposing of medicines. The Agency is able to accommodate support across the life cycle of the medicine, from early discovery through Innovation Task force meetings discussions to formal Scientific advice on pre authorization development or post marketing data generation. This is open to all developers including academic initiatives. In this area the Agency and the EU Regulatory Network is developing its capacity to perform horizon scanning and growing the adequate networking to support at the adequate level in the EU.
The session will present a comprehensive overview of the mechanisms that foster dialogue with developers and its regulatory advantage, including those that address very innovative medicines and methods. In addition, the topics of qualification, horizon scanning, and the role of the EU Innovation Network will be discussed to explore its interconnections and benefits to support fostering development for medicines in the EU. The session will reflect on the current situation and take stock for future developments. An interactive Q&A is foreseen for the last 30 minutes. This session will reflect on experience with these public hearings and will look at the lessons learnt and how these can be applied to future hearings. It will be followed by an interactive Q&A session.
- Laurence O'Dwyer - Scientific Affairs Manager, Health Products Regulatory Authority (HPRA), Ireland
- Falk Ehmann - Head of Innovation Task Force, European Medicines Agency (EMA)
- Thorsten Vetter - Scientific Administrator, Scientific Advice Office, European Medicines Agency (EMA)
|10:15 – 11:45
PS1: Combined Products - Drugs, devices, IVDs, software - how to regulate and innovate?
- Armin Ritzhaupt, Scientific Administrator, Regulatory Affairs Office, European Medicines Agency (EMA)
- Janine Jamieson, EU Editor, International Pharmaceutical Quality Publications, Sweden
The EMA/HMA, European Commission and TOPRA 2025 Strategies for the future of innovation, as well as the learnings from the current Covid-19 situation, all stress the need for greater collaboration across different stakeholder groups. With increasing convergence in healthcare, this requires co-operation between the medicines, medical devices and digital technologies sectors – involving regulatory agencies, device experts, notified bodies and academia.
How could such co-operation be implemented and utilised for the ultimate benefit of patients? This session will explore possible practical ways forward.
- John Wilkinson, Chair, Global Medical Device Nomenclature Agency, UK
- Christiana Hoffman, Team lead Non-active Devices and Article 117 MDR, TUV SUD, Germany
- Tim Chesworth; Senior Director Regulatory Affairs - Medical Devices & Combination Products, UK
- Ben Forbes, Professor of Pharmaceutics, King’s College London, UK
- Nick Hicks, Principal Consultant, Commutateur Advocacy Communication, France
Panel discussion with invited panellists Bassil Akra and Jessica Shull
|11:45 – 12:00
||Networking session: CT SPIN - Meet & greet with Christopher Price, Chair
|12:00 – 12:30
||How to make your RIM implementation successful - Networking session sponsored by
|12:00 – 13:30
||Networking session: Product Information and Labelling SPIN
|13:30 – 13:45
||Product demo: Streamlining change control and variation management - Networking session sponsored by
|13:45 – 14:45
TOPRA Annual Review Meeting
We invite all TOPRA members to attend the Annual Review Meeting to hear about TOPRA’s financial results for the previous year, key activities and achievements for the current year and plans for the next year. The meeting is an opportunity to be introduced to new Board Directors and celebrate the various awards and honours conferred by the Board to recognise significant contributions within our valued TOPRA Community.
|14:45 – 15:00
||Membership Q&A: Catch up with Sinead and Jamie from the TOPRA Membership Team
|15:00 – 16:30
HM5MD1: Innovation and regulation at the interface of medicines, devices and companion diagnostics
Leader and Chair: Janine Jamieson, EU Editor, International Pharmaceutical Quality Publications, Sweden
The EMA Strategic Reflection paper on Regulatory Science to 2025 outlines the need to create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products to:
- define how benefit-risk of borderline products is assessed and communicated
- enrich expertise at the interface between different medical products
- facilitate the regulatory pathway between notified bodies and medicines’ regulators
- and gain insight in innovation on drug-device combination products via horizon scanning.
Simultaneously, the new EU Medical Device and IVD Regulations coming into effect May 2021 and May 2022 respectively, call for greater integration with medicines regulatory pathways and bring in specific requirements for interactions between medicines competent authorities/EMA and notified bodies. This session will review the current situation and future outlook following the additional challenges brought about by Brexit and the COVID-19 pandemic.
Update from EMA on regulatory strategy initiatives
Speaker: Armin Ritzhaupt - Scientific Administrator, Regulatory Affairs Office, European Medicines Agency (EMA)
Innovative borderline products challenging current regulations
Speaker: Theresa Jeary, Technical Specialist & Scheme Manager, BSI, UK
Global development of IVDs, including companion diagnostics for personalised medicine
Speaker: Krystin Meidell, Senior Manager Medical Devices - Biogen Global Reg Lead on IVD/CDx and US regional lead, USA
Perspective of a national CA to support Innovation of medical products
Speaker: Ann Jans, Medical Devices Quality Assessor, The Federal Agency for Medicines and Health Products (FAMHP), Belgium
|15:00 – 16:30
||Substance Management in relation to SPOR (EU ISO IDMP/ SPOR) - hosted by the Regulatory Operations SPIN
|16:45 – 18:15
HM6: Innovation in clinical trials
Leaders and Chairs:
- Francesca Buttigieg, Global Program Regulatory Manager, Novartis, Switzerland (also session Chair)
- Daniela Drago, Senior Director, Regulatory Sciences, Biogen, US
New drug development trends see an increased focus on rare diseases, selective niches and heterogeneous conditions. These often require innovative ways to conduct clinical trials such as complex trial designs and global master protocols. Health Authorities around the world have been fostering new efficiencies in the review of clinical trial applications. Many encouraged more interactions between sponsors and regulators across different regions. Globally, the design, authorisation and management of clinical trials have had to evolve rapidly in extraordinary circumstances. The emergence of the Ebola epidemic and, more recently, the Covid-19 Pandemic, called for unprecedented ways to navigate through uncharted territories. Regulators and sponsors had to work together and find new ways to ensure the safety of trial participants, compliance with GCP, and minimization of risks to trial integrity. During this interactive session, we aim to discuss the intricacies of clinical trials, their evolution in line with current research trends and lessons learned from the management of clinical trials during a global crisis.
Challenges and opportunities in clinical trials' innovation: A physician voice with an industry perspective
Speaker: Diane Jorkasky, MD, FACP, Principal, Strategic Consultant, Diane K Jorkasky Consulting LLC, USA
- Elke Stahl, CTFG co-chair, BfArM, Germany
- Ann Marie Janson Lang, CTFG co-chair, MPA, Sweden