All Human medicines articles
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Journal
HM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Bjørg Hunter, Director, Regulatory Affairs Digital Health & IVD, Novo Nordisk, Denmark. Speakers: James Bertram, Director, Office of Combination Products, U.S. Food and ...
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Journal
HM9: Patient engagement in the regulatory lifecycle of medicines
Regulatory Rapporteur December 2023 | Volume 20 | No.11 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 ...
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Journal
HM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Marie Uguen, Senior VP, Regulatory Affairs & Quality Assurance, SparingVision, France. Speakers: Laurence Campion, Regulatory Affairs Director, PTC Therapeutics France, France. Christian K. Schneider, ...
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Journal
HM7: Paediatric investigational plans
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chairs: Sandra Lourenco, Head of Regulatory Affairs, Arriello, Portugal. Andrea Laslop, Head of Scientific Office, Austrian Medicines and Medical Devices Agency, Austria. Speakers: Ignacio Malagon ...
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Journal
HM3: A spotlight onto the future – fireside chat
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Francesca Buttigieg, Director Regulatory Affairs, PTC Therapeutics International Limited, Switzerland. Sabine Haubenreisser, Principal Scientific Administrator - Stakeholders and Communication, EMA, the Netherlands. Speakers: Steffen ...
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Journal
HM2: Improving the odds of regulatory success
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader and speaker: Carlos Langezaal, Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA. Speakers: Fred Senatore, Medical Officer, Clinical Team Leader Division of ...
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Journal
HM1: Update on EU new regulatory legislation − EMA, industry and others
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Leaders: Marta Marcelino, Head of Medicines Evaluation Department, PT CMDh Member, Infarmed, Portugal. Julie Taccoen, senior Director Regulatory Affairs, PTC Therapeutics, France. Speakers: Olga Solomon, Head ...
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Journal
HM4: The evolving clinical trial landscape
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Carlos Alves - Vice President, Infarmed, Portugal Speakers: Olga Kholmanskikh, Clinical Assessor, Federal Agency for Medicines and Health Products (FAHMP), Belgium. Björn Eriksson, Director ...
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Journal
HM1: A decade of innovative clinical trials: What have we learned and where are we going?
The session gave some insight on the Accelerating Clinical Trials in the EU (ACT EU) and the EMA Q&As on CCTs, a guidance regarding scientific aspects and the planning, set-up and submission for CTA applications, as well as conduct, reporting, analysis and interpretation of CCTs.
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Journal
HM2: Are expedited programmes delivering on the promise to accelerate drug development and patient access?
Expedited programmes available in the US, Europe and UK all aim to streamline process and ensure early access of medicinal products to patients; however, they are not yet fully delivering on their promises.
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Journal
HM3: Lessons learned and strategic priorities
The profession needs to adapt to the power of technology and the widespread dissemination of misinformation on social media is causing real-world harm.
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Journal
HM4: Assessing the value of innovative therapies: trends, challenges and learnings
This session focused on the evolution of the European Medicines Agency (EMA) and The European Network for Health Technology Assessment (EUnetHTA) collaboration.
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Journal
HM5: Digital health opportunities and advancements in healthcare
There are still many unanswered questions due to the silos between medicines and medical devices and there is a need for interdisciplinary cooperation – stakeholders with different skills – to optimally position Europe for innovation.
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Journal
HM6: Innovation in regulatory science – The path from data to evidence and the promise to streamline the regulatory lifecycle
There is a global evolution in drug development and RWE policy, increasing contribution of RWD/RWE to clinical evidence generation.
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Journal
HM7: Are patients the missing piece in the global drug development puzzle?
This session focused on patient engagement from different stakeholder perspectives.
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Journal
HM8: The present and future of developing and commercialising cell and gene therapies in a global world
Gene therapies are highly innovative products which have been approved only for the treatment of rare diseases so far. Changes in manufacturing processes during development as well as difficulties in gathering large clinical data sets explain the common challenges encountered by gene therapy developers to demonstrate the benefit of their ATMP.
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Journal
HM9: Strategy under uncertainty — Improving the odds of regulatory success
Following last year’s success, Daniela Drago, Carlos Langezaal and Fortunato Fred Senatore were back to conduct another interactive session. Attendees gathered into groups to discuss and propose regulatory strategies based on a number of scenarios, three of which will be described here.
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Focus
Brexit − Regulatory and supply chain considerations
The UK formally left the EU on 31 January 2020 and the transition period, as set out in the withdrawal agreement, came to an end on 31 December 2020. During this transition period, the UK continued to remain under EU pharmaceutical law. From 1 January 2021, the UK adopted an ...
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Meeting Report
HM3: Evolution of EMA-EUnetHTA collaboration across decision makers
This session focused on the evolution of the European Medicines Agency (EMA) and The European Network for Health Technology Assessment (EUnetHTA) collaboration.
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Meeting Report
HM1: Spotlight on CEE – challenges and opportunities in the region
The first session of this virtual symposium was opened by Eva Kopecna, who introduced three speakers, two of whom represented two different regulatory agencies – the Czech State Institute for Drug Control (SÚKL), which is part of the EU regulatory community, and the Russian State Institute of Drugs and Good Practices (SID&GP).