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All times CEST (GMT+2) |
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8:30 – 9:00
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Registration |
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9:00 – 10:30 |
SME1: Regulatory Support to SMEs, Academia and Start-ups including authority interactions
09:00-09:05 Welcome from Chair – Margareth Jorvid
09:05-09:25 European Medicines Agency - Support to SMEs and Academia – Leonor Enes, European Medicines Agency (EMA), SME Office, the Netherlands
Support to SMEs - SME Office
Support to academia
EMA support to innovation
09:25-09:45 Local support from Infarmed to Academia and Start-ups - Helena Baião, Infarmed, Portugal
How to prepare for and contact the Agency
National scientific advice
Experience of national support
09:45-10:05 The regulatory experience of a SME, industry representative - Dr. Miguel Forte, Managing Director, mC4Tx and President-Elect, International Society for Cell and Gene Therapy, Belgium
When to talk to the Regulators?
Formal meeting with FDA
Practical experiences
10:05-10:30 Panel discussion
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Delegates also have the option to follow a human medicine, medical device, IVD or a parallel stream for the rest of the day |
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9:00 - 10:30 |
HM7: Paediatric Investigational Plans
Session Leaders:
Dr. Andrea Laslop - Head of Scientific Office, Austrian Medicines and Medical Devices Agency (MEA), Austria
Sandra Lourenço - Head of Regulatory Affairs, Arriello, Ireland
Since the paediatric legislation in the EU came into effect in the EU more than 15 years ago, much has been accomplished to improve the development and availability of medicines for children.
In this session we will discuss how these achievements can be continuously expanded by addressing further disease areas and treatment modalities where unmet medical needs currently persist.
The regulatory procedures for establishment of paediatric investigation plans are expected to benefit from a revised approach that will be tailored in a step-wise process to actual stages of development.
Finally, we will address how global development of paediatric medicines can be facilitated by strengthening the collaboration and alignment of regulatory requirements for paediatric clinical trials and investigation plans on an international level.
Speakers will include:
Prof. Ignacio Malagon -Prof. of Paediatric Anaesthesia, Radboud UMC, the Netherlands
Karl-Heinz Huemer - Consultant, KHH Consultancy, Austria
Dr. Martine Dehlinger-Kremer - Vice President Scientific Affairs, Pediatric Subject Matter Expert, Icon-PLC & President EUCRO, Germany
Panellists will include:
Chrissi Pallidis - Senior Scientific Specialist, EMA, the Netherlands
Solange Corriol-Rohou - Senior Director Regulatory Affairs & Policy, AstraZeneca, France
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9:00 - 10:30 |
MD3: Navigating the Regulatory Maze: Challenges of Medical Device Software
Session Leader:
Dr. Célia Cruz - Chief Regulatory Affairs Officer, Complear Health, Portugal
As the healthcare industry rapidly embraces digital transformation, medical device software has gained significant momentum. However, with the implementation of the Medical Devices Regulation (MDR), manufacturers and different stakeholders are faced with many challenges. This panel brings together industry experts to shed light on the complex landscape of regulation from the medical device software perspective. Discover how to navigate the MDR's rigorous classification process, ensure robust clinical evaluations, and address the unique challenges associated with medical device cybersecurity and privacy. Through practical insights and expert advice, this panel aims to equip attendees with the knowledge and strategies needed to overcome obstacles and thrive in the evolving landscape of medical device software.
Speakers will include:
Mariana Madureira – Senior Officer at Health Products Directorate, Infarmed, Portugal
Introduction, concepts and challenges from Competent Authority perspective, including qualification medical device software and hardware-software interaction.
Abtin Rad – Global Director Functional Safety, Software and Digitization, TÜV SÜD Product Service GmbH, Germany
Concepts and challenges from Notified Body perspective, including cybersecurity and artificial intelligence.
Erik Vollebregt – Partner / Attorney-at-Law, Axon Lawyers, the Netherlands
Concepts and challenges from the industry perspective, including artificial intelligence challenges and economic operators.
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9:00 - 10:30 |
IVD3: IVDR: The Current State
Session Leaders:
Amanda Brown - Director of Quality and Regulatory Affairs, HP, Germany
Ashleigh Batchen - Regulatory Strategy Principal (UK), TÜV SÜD, UK
Now that IVDR has accumulated in the last few years, this session offers an update on the current status of IVDR progression and implementation within the European Union. During this session we will hear perspectives from a range of stakeholders covering what has been observed so far, lessons learned, and what is coming in the future.
Speakers will include:
Olga Tkachenko – Policy Officer, European Commission Belgium
Stefan Burde – Director Global Focus Team IVD, TÜV SÜD Product Service, US
Dr. Lena Björk – Director Supervision, Läkemedelsverket/Medical Products Agency (MPA), Sweden
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10:30 - 11:00 |
Networking break |
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11:00 - 12:30 |
HM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)
Session Leaders:
Marie Uguen - Chief Regulatory Affairs & QA, SparingVision, France
Timely access to safe and effective therapies for patients is the essence of drug development. Regulators, often supported and sometimes prompted by third parties, have been creative in designing and testing regulatory mechanisms to expedite drug development and patient access.
In this session, regulators and senior industry representatives will provide an overview of existing regulatory mechanisms supporting streamlined drug development and patient access, illustrated by concrete case studies.
Speakers will include:
Laurence Campion - Regulatory Affairs Director, PTC Therapeutics France, France
Dr Christian K. Schneider - Vice President, Head of Biopharma Excellence, Chief Medical Officer (Biopharma), PharmaLex, Denmark
Dr. Valérie Denux - Head of Europe & Innovation Division, ANSM, France
Bettina Ziegele - Head Innovation Office, Paul-Ehrlich-Institut, Germany
Panellists will include:
Momir Radulović - Executive Director, Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)/ Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Slovenia
Dr. Kevin Cunningham - EMA PRIME Scientific Coordinator, EMA, the Netherlands
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10:00 - 11:30 |
PS1: HTAs - the new regulation in the EU
Session Leaders:
Mariane Cossito - Head of Medicines Evaluation and Access Management Unit, INFARMED, Portugal
Dr. Carlos Langezaal - Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA
The Regulation on Health Technology Assessment (HTA) was adopted in December 2021, entered into force in January 2022, and it will be applied in a three year timeframe (January 2025). In this three year delayed application period, the intention is to set up the organisational framework of the HTA Regulation, and to adopt the implementation and delegated acts and methodological guidance documents. In this session, an overview of the progress and plans of the Coordination Group and Stakeholder Network will be provided.
Speakers will include:
Roisin Adams - Head at HTA Strategy and External Engagement National centre for Pharmacoeconomics, National Centre for Pharmacoeconomics (NCPE), Ireland
Dr. Tina Wang - Senior Manager, HTA Strategic Partnership, Centre for Innovation in Regulatory Science (CIRS), UK
Rui Santos Ivo - Presdient, Infarmed, Portugal
Panellists will include:
Michael Berntgen - Head of Scientific Evidence Generation Department, EMA, the Netherlands
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11:00 - 12:30 |
MD4: Challenges and opportunities for small companies and start ups
Session Leader and Chair:
Margareth Jorvid - Chief Executive Officer, Methra Uppsala AB, Sweden
Bringing a medical device to market is a challenge, especially as a small company or startup. This session will address the challenges faced by small companies based in Europe but also in other regions, share experience of implementation of the new Regulation (EU) 2017/745 (MDR) and discuss how to CE mark your device. How to do the right things from the start and use the right tools. How to approach and talk to a Notified Body. In the end it is making your device available to the benefits of patients that counts.
Speakers will include:
Martin Witte - Senior Director, TÜV SÜD Product Service GmbH, Germany
There will be an MDR update, coverage timelines and a discussion on how to support innovation. Notified body perspectives will be explored and guidance on what to do and not do.
Hasnaa Fatehi - Founder and Principal Consultant, Qaralogic Consulting, Inc., Canada
The EU-MDR Experience will be covered withaccounts from Canada to Taiwan.
André Fazenda– Regulatory Affairs, Peek Health, S.A., Portugal
Sharing experiences of Medical Device Regulation (MDR) from a local company in Portugal.
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11:00 - 12:30 |
IVD4: How to Manage Diverging Regulatory Strategies within a Global Market (China, US, and EU)
Session Leaders:
Amanda Brown - Director of Quality and Regulatory Affairs, HP, Germany
Ashleigh Batchen - Regulatory Strategy Principal (UK), TÜV SÜD, UK
The global focus and distribution strategies of many IVD companies, combined with diverging international regulatory requirements, leave many regulatory professionals challenged with how to meet commercial launch timelines. This session will compare some of the regulations and requirements for submission across selected global markets, and discuss possible options to optimize efficiencies.
Speakers will include:
Maurizio Suppo – Vice President – Principal Consultant, QARAD - QbD Group, Belgium
Hamish King – Chief Executive Officer, Cisema, Hong Kong
Dr. Karin A. Hughes– Senior Vice President, Global Regulatory and Quality, Beaufort, US
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12:30 - 14:00 |
Lunch |
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14:00 - 15:30 |
HM9: Patient engagement in the regulatory lifecycle of medicines
Session Leaders:
Fred Senatore - Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research, U.S. Food and Drug Administration (FDA), USA
Sabine Haubenreisser - Principal Scientific Administrator - Stakeholders and Communication, EMA, the Netherlands
In this session, we will illustrate how patients are involved throughout the development of medicines until the decision is made on the marketing authorisation application and post-authorisation both in the EU and in the US. Interaction with patients have evolved constantly, with patients being represented in the European Medicines Agency Management Board, Scientific Committees and patients contributing to Scientific Advice, Expert meetings and Committee discussions. FDA is holding listening sessions and patient focus drug development meetings and asking concrete questions on study designs and patients’ expectations.
Hear from various stakeholders how patients have successfully contributed to decision making of regulators and how this process will be further strengthened.
Speakers will include:
Maria Mavris - Patient Relations, EMA
Andrea Furia-Helms - Director, Patient Affairs, U.S. Food and Drug Administration, USA
Dr. Maren von Fritshcen - Head Regulatory Policy Europe, Moderna, Germany
Dr. Kieran Breen - Research Advisor, Parkinson's Europe United Kingdom
Dr. Joao Oliveira - M.D., Instituto Português de Oncologia de Lisboa, Portugal
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14:00 - 15:30 |
PS2: ATMP innovations and clinical trials with GMOs
Session Leader:
Jayne Hunt - Principal Consultant, Ariello, Ireland
In May 2023 members of the TOPRA Biotech and Clinical Trial SPIN groups published an article in the Regulatory Rapporteur on the topic of ‘Evolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR’. As many SMEs work in the area of innovative medicinal products, this session will consider some of the new innovative development areas including off-the-shelf ATMPs. We are very fortunate to have Maria Isabel Borba Vieira (INFARMED & alternate CAT member) to provide some considerations on innovation from the Committee for Advanced Therapies perspective, as well as providing some thoughts on the use of non-clinical studies to support innovative clinical studies. Finally, we take some considerations from the TOPRA article with a case study relating to the GMO regulation and the impact of this on innovative clinical trial registration via the Clinical Trial Information System (CTIS).
Speakers will include:
Dr. Patrick Ginty -Senior Director, Regulatory Affairs, Boyds, UK
Maria Isabel de Medeiros Borba Vieira - Non-clinical Assessor, Infarmed, Portugal
Pierre-Frédéric Omnes - Executive Director, Life Sciences, TransPerfect, France
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14:00 - 15:30
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MD5: Post-market challenges
Session Leader:
Natasha Bankowski - Director of Regulatory Affairs and Quality Assurance, Beyond Air Ireland Ltd, Ireland
For IVD and Medical Device manufacturers, post-market and vigilance challenges, as well as maintaining regulatory intelligence have increased significantly with the MDR, IVDR and other global changes. The impact of these challenges places a huge burden on companies and resources to keep up with these complex challenges.
Post-market surveillance activities even for the lowest risk classes have dramatically increased along with your vigilance requirements. Keeping a product state of the art and on the market post-launch may prove to be even more difficult for some companies than actually launching the product.
This session will bring together key stakeholders from the competent authority, notified body and industry to discuss these challenge and provide some guidance on solutions that may help going forward.
Speakers will include:
Maria Raquel Alves - Healthcare Products Vigilance Unit Director, Infarmed, Portugal
Vigilance and Reporting challenges for Medical Devices and IVDs.
- Vigilance a part of Post-market Surveillance System
- Vigilance reporting according MDR and IVDR
- Some of the main challenges on vigilance reporting according MDR and IVDR
Alice Forde - Director, Regulatory Affairs Europe, Bausch + Lomb, Irelandal Devices and IVDs.
Maintaining Regulatory Intelligence post-market.
- Shared challenges – multinationals, SMEs and everything in between
- Local vs Regional requirements – what happens when they don’t align?
- Importance of being connected to your network
Richard Vincins - VP Global Regulatory Affairs, Oriel STAT A MATRIX, United Kingdom
Post Market Surveillance challenges and solutions
- PMS Planning – Addressing timing of reports and correct source input
- Economic Operator challenges and their role in the PMS system
- Linkages of Risk Management and Significant changes to the PMS system
- Case study in relation to a PMS report
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14:00 - 15:30 |
IVD5: Class D IVDs
Session Leader:
Amanda Brown - Director of Quality and Regulatory Affairs, HP, Germany
Ashleigh Batchen - Regulatory Strategy Principal (UK), TÜV SÜD, UK
This session will look at the challenges, solutions and requirements.
Due to the increased risk associated with specific IVDs, the IVDR places additional regulatory scrutiny on these products. This session will navigate some of these additional complexities for class D IVDs, including reference laboratories, post-market surveillance requirements, and how to manage conformity assessment.
Speakers will include:
Maurizio Suppo – Vice President - Principal Consultant, QARAD - QbD Group, Belgium
Stefan Burde – Director Global Focus Team IVD, TÜV SÜD Product Service, USA
Dr. Stefan Scheib - Global Head of Regulatory Affairs (Network), Core Lab, Roche Diagnostics (RDS), Germany
Thomas McDonagh - Associate Director Regulatory Affairs (IVDR), Abbott Core Diagnostics, Ireland
Panellists will include:
Olga Tkachenko – Policy Officer, European Commission, Belgium
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End of the Regulatory Updates for Start-ups, SMEs and Academia Symposium |