All Journal articles – Page 5
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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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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 ...
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JournalVM2: New initiatives in regulatory science
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Speakers: Raffaele Bruno, Associate Director, Regulatory Affairs, Zoetis Inc., Belgium. Michael Empl, Scientific Specialist, Toxicology & Environmental Risk Assessment, European Medicines Agency, Netherlands. Tony Humphreys, Head of ...