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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 EUCROF, 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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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 - Senior VP, Regulatory Affairs & Quality Assurance, 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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PS1: Health Technology Assessments – the new EU regulation
Session Leaders:
Mariane Cossito - Head of Medicines Evaluation and Access Management Unit, Infarmed, Portugal
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 - President, Infarmed, Portugal
Panellists will include:
Michael Berntgen - Head of Scientific Evidence Generation Department, EMA, the Netherlands
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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 (FDA), USA
Dr. Maren von Fritschen - 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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PS2: ATMP innovations and clinical trials with GMOs
Session Leader:
Jayne Hunt - Principal Regulatory Affairs 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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End of the Human Medicines Symposium |