All Regulatory Rapporteur articles in December 2023
View all stories from this issue.
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JournalMD3: Navigating the regulatory maze: challenges of medical device software
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Dr. Célia Cruz, Chief Regulatory Affairs Officer, Complear Health, Portugal. Speakers and panelists: Mariana Madureira, Senior Officer at Health Products Directorate, Infarmed, Portugal. Abtin Rad, ...
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JournalMD2/IVD2:
Medical technologies −
a catalyst for
regulatory innovationsRegulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader Alwin van den Broek, Medical Devices Professional, the Netherlands. Maaike Labots, Manager Medical Writing, Avania Clinical, the Netherlands. Speakers and panelists Maryam Atakhorrami, Global ...
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JournalHM5/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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JournalTOPRA Annual lecture
Dr Miguel Forte started his lecture by describing the fantastic cell and gene therapies (C>) opportunity for patients and other stakeholders in the pharmaceutical industry; he described a complex business with significant investment and value to patient in oncology and rare disease.
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EditorialAdvancing global
healthcare togetherAn annual fixture since 2004, TOPRA’s Symposium is Europe’s premier conference for regulatory affairs professionals with dedicated programme streams for human and veterinary medicines, medical devices and IVDs. This year the Symposium was in Lisbon, in partnership with Infarmed, Portugal’s national authority of medicines and health products.
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JournalHM9: 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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JournalHM8: 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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JournalHM7: 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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JournalHM6: Real-world evidence and the use of big data for regulatory decision making; DARWIN EU
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Marén Koban, Director Global Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany. Àlmath Spooner, Head of Europe, Regulatory Policy and Intelligence, Abbvie, Ireland. Speakers: ...
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JournalVM5: Digital innovation to support animal health
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jana Schalansky, Head of Veterinary Strategic Support, Veterinary Medicines Division, EMA, the Netherlands. Speakers: Ricardo Carapeto García, Head of Area and Environmental Risks, AEMPS, ...
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JournalIVD5: Class D IVDs
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session Leader Amanda Brown, Director of Quality and Regulatory Affairs, HP, Germany. Ashleigh Batchen, Regulatory Strategy Principal (UK), TÜV SÜD, UK. Speakers and panelists Olga Tkachenko, ...
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JournalMD5: Post-market challenges
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Natasha Bankowski, Director of Regulatory Affairs and Quality Assurance, Beyond Air Ireland Ltd, Ireland. Speakers: Richard Vincins, VP Global Regulatory Affairs, Oriel STAT A MATRIX, ...
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JournalVM4: Living with post-authorisation obligations – progress, challenges and future opportunities
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: João Pedro Duarte da Silva, Senior Officer, Veterinary Medicines Unit, General Directorate for Food and Veterinary (DGAV), Portugal. Speakers: Katherine Schirmann, Scientific Officer, The ...
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JournalIVD4: How to manage diverging regulatory strategies within a global market (China, US and the EU)
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders Amanda Brown, Director of Quality and Regulatory Affairs, HP, Germany. Ashleigh Batchen, Regulatory Strategy Principal (UK), TÜV SÜD, UK. Speakers Maurizio Suppo, Vice President ...
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JournalMD4: Challenges and opportunities for small companies and start-ups
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Margareth Jorvid – Chief Executive Officer, Methra Uppsala AB, Sweden. Speakers and panellists: Martin Witte, Senior Director, TÜV SÜD GmbH, Germany. Hasnaa Fatehi, Founder and ...
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JournalHM3: 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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JournalIVD3: IVDR: Current state
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leads: Amanda Brown, Director of Quality and Regulatory, HP, Germany. Ashleigh Batchen, Regulatory Strategy Principal, TÜV SÜD, UK. Speakers: Olga Tkachenko, Scientific Policy Officer, European ...
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JournalVM3: Regulatory exchange and new/future approaches
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Dr Mel Munro, Global Lead, Regulatory Science, knoell Animal Health, UK. Speakers: Beate Gasser, CMDv Vice Chair, Austrian Federal Office for Safety in ...
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JournalHM2: 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 ...