Programmes

Content for the 2020 TOPRA Symposium is in development. Updates to the programmes will be made regularly in advance of the event, so please refer back to this page to remain current on additions and modifications to session topics and timings, and changes to speaker participation.

Download our Programme at a glance (PDF)

Please note: all session times are British Summer Time (GMT+1).

Human Medicines Symposium | TOPRA Symposium 2020

Pre-event | 29 September

All times BST (GMT+1) 
13:00 – 14:00

Virtual tour of the Symposium online platform

14:15 – 14:30 Welcome to the 2020 Symposium

14:30 – 15:30 Annual Lecture: Responding to Disease X … A Regulatory Perspective
Speaker: Debra Yeskey, Head of Regulatory Affairs, North America, Coalition for Epidemic Preparedness Innovations (CEPI), USA

The presentation will introduce audience to CEPI as an organization and its mission/vision. It will cover CEPI’s pre-COVID portfolio to include Disease X and early days in the Wuhan outbreak.  The presentation will also outline current activities and work with WHO and Gavi to include regulatory challenges in this pandemic.

15:45 – 16:45 PD1: Know thyself! Getting curious about unconscious bias
Speaker: Joe Cheal, Lead Imaginarian and Trainer, Imaginarium Learning and Development, UK

To be human is to be biased … but how can we identify the unconscious biases that may be impacting on the relationship you have with yourself and with other people? Rather than beating yourself up for being bias, this session will help you to ‘surface’ what is usually unconscious, to explore why we do it and, most importantly, how we can ‘clean up our act’!

 

5 October

All times BST (GMT+1)
9:00 – 10:30

HM1: Driving the healthcare regulatory system into the future
Leader and Chair: Greet Musch, General Director DG PRE authorisation, The Federal Agency for Medicines and Health Products (FAMHP), Belgium

Starting with the formation of the new European Commission at the end of 2019 and continuing with the development and endorsement of the EMA Regulatory Science Strategy to 2025, this past year has been one of learning from the past, reflecting on the present and planning for the future. Throughout this session, we will discuss how will the current European regulatory system evolve and make use of technological developments, advance regulatory science and continue to foster innovation, furthering its ever so important public health mission.

Speakers:

  • Xavier de Cuyper - Chief Executive Officer, The Federal Agency for Medicines and Health Products (FAMHP), Belgium
  • Guido Rasi -  Executive Director, European Medicines Agency (EMA)
  • Sini Eskola, Director, Regulatory, Drug development and Manufacturing, EFPIA, Belgium
  • Thomas Senderovitz, Director General, Danish Medicines Agency (DKMA), Denmark
  • Olga Solomon, Head of Unit B5, DG Sante, European Commission

9:00 – 10:30 Networking session: TOPRA In Central & Eastern Europe: CT & MD Regulation implementation
10:30 – 11:00 Connecting Regulatory and Quality: Streamlining change control and variation management - Networking session sponsored by  Veeva Logo
11:00 – 12:15 Networking session: TOPRA In India Q&A
11:30 – 12:30

Networking session: Meet the Regulatory Rapporteur editorial board

Hosted by: Benedict Lam, Managing Editor, and Leslie Dowling, Editor in Chief, Regulatory Rapporteur, TOPRA, UK

This is an opportunity for Symposium attendees to learn more about your professional journal. Pop in for an informal chat and meet some of our Consultant Editors and Officers from Regulatory Rapporteur’s Editorial Board. Perhaps you would like to ask our Consultant Editors why they decided to join the Editorial Board? Perhaps you have an idea for an article and would like to pitch it to the journal team? Or maybe you are just curious about what is involved in producing Regulatory Rapporteur, which has informed the profession for many decades and attracts contributing authors from all over the world? Drop in for 15 minutes or stay for the hour! All are welcome.

12:30 - 13:00  Biosimilars - Easing Market Entry into BRICS-TM - sponsored by  Mettina logo
12:30 – 14:00

HM2: Expansion of regulatory innovation in other markets 
Co-Leaders and Chairs:

  • Daniela Drago, Senior Director, Regulatory Sciences, Biogen, USA
  • Carlos Langezaal, Senior Director, Global Regulatory Affairs, Bristol Myers Squibb, USA

Regulators, industry officials, and other stakeholders are under mounting pressure to improve performance and facilitate timely access to safe, effective and quality innovative medical products. The task has become even more challenging due to globalization, increasingly complex technologies and growing public expectation. Many see the benefit of strengthening the regulatory systems through convergence, reliance, and recognition. Several initiatives are under way and this session will discuss them. The speakers will provide different perspectives and debate benefits, limitations and hurdles in designing and implementing such initiatives. Join us for a discussion on challenges and opportunities of fostering systems that facilitate innovation, ensure patient safety and promote public health.

Speakers:

  • Thomas Kühler - Head Global Regulatory Science & Policy EU/AMESA, Sanofi, France
  • Yasuhiro Kishioka -  MHLW/PMDA Liaison Official, International Affairs Division, European Medicines Agency
  • Samvel Azatyan - Team Lead, Regulatory Convergence and Networks, Unit Head a.i., Regulation and Safety, World Health Organization (WHO)

Panellist: Marie-Helene Pinhiero - Industry Stakeholder Liaison, European Medicines Agency (EMA)

14:00 - 14:30 The leading global solution for all your proofreading tasks - networking session sponsored by  Schlafender Hase
14:15 – 15:45 Regulatory robotic process automation, with Q&A - networking session hosted by the Regulatory Operations SPIN
15:00 – 15:30  Networking session: Meet & greet with the new Patient Engagement SPIN Steering Group
16:00 – 16:15  Membership Q&A: Catch up with Sinead and Jamie from the TOPRA Membership Team 
16:00 – 17:30 

HM3: Orphan and paediatric policy updates
Leader and Chair: 

  • João Duarte, Director, Regulatory Science and Chief of Staff, Global Regulatory Affairs, Alexion, France

Since their introduction in 2000 and 2007 respectively, the orphan and paediatric regulations have been at the basis of a number of therapeutic breakthroughs and incentivised companies to bring to the market more medicinal products for these therapeutic areas. However, with 95% of rare diseases not having any treatment options, the level of unmet medical need remains high. How can we best make use of the available pathways to address this? What can we learn from other regions? And what further tools do we need? This session will aim to discuss this questions and provide updates to ongoing regulatory and legislative developments in this fields.

Speakers:

  • Koenraad Norga - Paediatric Committee (PDCO) chair, Universitair Ziekenhuis Antwerpen, Belgium
  • Kaja Kantorska - Policy Office, Unit B5, DG Sante, European Commission
  • Fabio D'Atri - Policy Officer, Unit B5, DG Sante, European Commission

 

6 October

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.

Speakers:

  • 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?
Chairs:

  • 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.

Speakers

  • 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  Kinapse logo
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  Veeva logo
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

Panel Discussion

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

Additional speakers:

  • Elke Stahl, CTFG co-chair, BfArM, Germany
  • Ann Marie Janson Lang, CTFG co-chair, MPA, Sweden 

 

7 October

All times BST (GMT+1)
10:30 – 10:45  Membership Q&A: Catch up with Sinead and Jamie from the TOPRA Membership Team 
10:45 – 12:15 Networking session: Meet & greet with the CMC SPIN Steering Group 
10:45 – 12:15

HM7: Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning?
Leader and Chair: Michael Berntgen, Head of Product Development Scientific Support Department, European Medicines Agency (EMA)

Decision-making by regulators and HTA bodies on the pathway to patient access occur in a sequential way with different remits. In the context of the cooperation between EMA and EUnetHTA experience has been gained with regard to the scientific considerations for such reviews at market entry. To enhance mutual understanding and facilitate decision-making, the framework of joint REA production by EUnetHTA includes a direct exchange between regulators and HTA bodies. With more than 10 products having undergone such process it is an opportunity to review the learnings also in view of potential prospective evidence planning for future developments. Furthermore, a multi-stakeholder review on post licensing evidence generation and opportunities for earlier interaction has recently been concluded to guide future product specific discussions on evidence planning. This session will review experiences in this space to optimise evidence planning by sponsors and facilitate and exchange across stakeholders also in view of the evolving framework for HTA in Europe.

Review of joint production by EUnetHTA and opportunities for development planning
Speaker: Niklas Hedberg, EUnetHTA / TLV, Sweden

Learnings from the exchange between EMA and HTA bodies for evidence generation
Speaker: Paula van Hennik, CHMP / MEB, the Netherlands

Sponsors' perspective how to translate such learnings into evidence plans
Speaker: Maren von Fritschen, Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium

How the future European framework could facilitate such discussion
Speaker: Flora Giorgio, Head of Sector, HTA, DG SANTE, European Commission

Panel discussion

12:15 – 12:25  PharmaLex and the new normals - sponsored by  
12:25 – 12:35 Looking ahead to Brexit - sponsored by   
12:45 - 13:15  The DLRC Difference – Why choose to work with us? - sponsored by  DLRC logo
13:00  14:15  Hiring into regulatory and the importance of employer branding - sponsored by  pharmiweb.jobs
14:15 – 15:45

HM8: Patient centricity in regulatory affairs and involvement in evidence generation
Leader and Chair: Susan Bhatti, Director EU Global Regulatory and Scientific Policy, Merck BV, the Netherlands

Patient centricity has become a catch phrase in pharmaceutical companies and is high on the agenda of Health Authorities in Europe and USA. However, capturing the voice and preferences of patients reliably and in a representative manner is not an easy task. Selecting an appropriate patient population and method is key to obtaning evidence that will withstand scrutiny by Health Authorities and support their regulatory decision making. In this session a patient representative will talk about their experience of patient centric research, an industry view on capturing the patient voice and the IMI-PREFER project will be presented and an Agency expert will provide insights on engaging with patients and patient representatives during scientific advice and early clinical development.

The patient experience of patient-centric research
Speaker: Erik Briers, Expert Patient Advocate - Board Member, Patient Expert Committee (PEC), Belgium

Engaging with patients and patient representatives during scientific advice and early clinical development
Speaker: Christophe Lahorte, Head of National Innovation Office & Scientific-Technical Advice Unit, The Federal Agency for Medicines and Health Products (FAMHP), Belgium

Capturing the patient voice on benefits and risks of medicinal products
Speaker: Susan Bhatti, Director EU Global Regulatory and Scientific Policy, Merck BV, the Netherlands

Panel Discussion with invited panelist Maria Mavris, Patients and Consumers Liaison, European Medicines Agency (EMA)

14:30 – 15:00 Networking session: Medtech SPIN Steering Group meet & greet
16:00 – 16:30

PD2: How can TOPRA help you and your organisation with professional development?
Speaker: Samantha Cooper, Director of Professional Development, TOPRA, UK

Professional registration can motivate and engage staff, foster an environment of continuous improvement and provide recognition for individuals and companies. Come to this session to hear more, get your questions answered and discuss any professional development issues you have.


End of Human Medicines Symposium

 

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TOPRA Symposium 2020
Pre-event session: 29 September
Symposia: 5–8 October
Online

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