All Journal articles – Page 3
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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 ...
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JournalPS2: ATMP innovations and clinical trials with genetically modified organisms
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jayne Hunt, Principal Regulatory Affairs Consultant, Ariello. Speakers: Patrick Ginty, Boyds Consultants. Isabel Borba Vieira, Nonclinical Assessor at Medicines Evaluation Department Scientific Evaluation Unit, ...
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JournalHM1: 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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JournalVM1:
Horizontal legislation and
veterinary medicine availabilityRegulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Rick Clayton, Technical Director, AnimalhealthEurope, Belgium. Speakers: Jaume Colomer, Senior Technical Manager, AnimalhealthEurope, Belgium. Nancy De Briyne, Executive Director of the Federation of Veterinarians ...
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JournalPS1:
Health technology assessment –
the new EU regulationRegulatory Rapporteur December 2023 | Volume 20 | No.11 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. Speakers: ...
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JournalHM4: 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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JournalControlled substances development – past, present, and future
Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...
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JournalOverview of importation
strategy from an
FDA perspective
– PLAIR vs FTZIn the current landscape, pharmaceuticals and biologics are manufactured at global current good manufacturing practice facilities for distribution in the US market. The importation of these products is a crucial process, as it ensures that patients can access these products in a timely fashion upon approval of applications to health ...
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JournalAccess consortium: in the current submission transmission ecosystem
The Access Consortium is a medium-sized coalition of regulatory authorities that work together to promote greater collaboration and alignment of regulatory requirements. This union began in 2007 with the involvement of Australia, Canada, Singapore, and Switzerland, and was later in 2021 bolstered by the addition of the United Kingdom’s Medicines ...
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JournalMedical device standards update: November 2023
This edition of our regular column updates the progress of applicable standards to October 2023.