All Journal articles – Page 3

  • 2D4A7041
    Journal

    VM5: Digital innovation to support animal health

    2023-12-05T16:00:00Z

    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, ...

  • IVD5
    Journal

    IVD5: Class D IVDs

    2023-12-05T16:00:00Z

    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, ...

  • Richard Vincins
    Journal

    MD5: Post-market challenges

    2023-12-05T16:00:00Z

    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, ...

  • VM4
    Journal

    VM4: Living with post-authorisation obligations – progress, challenges and future opportunities

    2023-12-05T16:00:00Z

    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 ...

  • IVD4_Karim Hughes
    Journal

    IVD4: How to manage diverging regulatory strategies within a global market (China, US and the EU)

    2023-12-05T16:00:00Z

    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 ...

  • MD4
    Journal

    MD4: Challenges and opportunities for small companies and start-ups

    2023-12-05T16:00:00Z

    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 ...

  • HM3
    Journal

    HM3: A spotlight onto the future – fireside chat

    2023-12-05T16:00:00Z

    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 ...

  • IVD3
    Journal

    IVD3: IVDR: Current state

    2023-12-05T16:00:00Z

    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 ...

  • VM3
    Journal

    VM3: Regulatory exchange and new/future approaches

    2023-12-05T16:00:00Z

    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 ...

  • 2D4A5460
    Journal

    HM2: Improving the odds of regulatory success

    2023-12-05T16:00:00Z

    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 ...

  • 2D4A5414
    Journal

    VM2: New initiatives in regulatory science

    2023-12-05T16:00:00Z

    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 ...

  • PS2
    Journal

    PS2: ATMP innovations and clinical trials with genetically modified organisms

    2023-12-05T16:00:00Z

    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, ...

  • 2D4A4912
    Journal

    HM1: Update on EU new regulatory legislation − EMA, industry and others

    2023-12-05T16:00:00Z

    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 ...

  • VM1_Rick Clayton
    Journal

    VM1:
    Horizontal legislation and
    veterinary medicine availability

    2023-12-05T16:00:00Z

    Regulatory 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 ...

  • PS1
    Journal

    PS1:
    Health technology assessment –
    the new EU regulation

    2023-12-05T16:00:00Z

    Regulatory 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: ...

  • RR-Dec-2023-Cover
  • HM4_Panel
    Journal

    HM4: The evolving clinical trial landscape

    2023-11-07T15:25:00Z

    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 ...

  • AdobeStock_540782876
    Journal

    Controlled substances development – past, present, and future

    2023-11-03T00:05:00Z

    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, ...

  • AdobeStock_659335173
    Journal

    Overview of importation
    strategy from an
    FDA perspective
    – PLAIR vs FTZ

    2023-11-03T00:05:00Z

    In 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 ...

  • AdobeStock_628375803
    Journal

    Access consortium: in the current submission transmission ecosystem

    2023-11-03T00:05:00Z

    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 ...