• February 2024 – Contents

  • Sink or swim: the changing tides of device regulation

  • AI meets medtech: big opportunities require a measured approach

  • EU MDR implementation – what is changing for the medical device industry?

  • Chemical characterisation: a critical first step for medical device development

  • The rise of FemTech and why compliance is key to its success

  • Overview of medical device regulations in Canada

  • China drug master file: registration pathways and requirements

More news

Pharmacy-First-Service-NHS-England

NHS Pharmacy First offers an alternative to GPs in England

Pharmacists in England can now provide treatment for seven common health conditions without patients first consulting a doctor.

AUS-UK joint agency vetmed approval process agreed

The UK’s VMD and Australia’s APVMA have published guidance for the simultaneous review of veterinary medicines submissions.

Disposable vapes set to be banned in Britain by 2025

UK Prime Minister Rishi Sunak has announced a ban on disposable vapes, expected to be enforced in England, Wales and Scotland from 2025.

£34m NIHR funding open to researchers from LMICs and UK

The NIHR has announced a new award to help create career opportunities for researchers from low-and middle-income countries and the UK.

Non-surgical gastric balloon to be made available on NHS

A novel gastric ‘balloon’ medical device has been made available on the UK’s National Health Service (NHS) for the first time.

Feb-24-Podcast-artwork-Webvision

RegRapPod − February 2024

2024-02-20T16:51:00+00:00By

Vol.21 #2: In February 2024’s RegRapPod, host Alan Booth talks to Issue Editors Dejan Brkic and Esteban Herrero-Martinez about medtech.

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RegRapPodIn Conversation with TOPRA’s RegOps SPIN

2024-02-02T00:05:00+00:00By

BONUS EPISODE: In Conversation with TOPRA’s RegOps SPIN

  • January 2024 – Contents

  • The increasing complexity of biological medicinal products

  • Navigating early drug development investment: a detailed guide to due diligence

  • A weight of evidence approach for the non-clinical evaluation of complex biologicals

  • Innovating and harmonising access and requirements amid the global regulatory challenges of biologics

  • Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies

  • The changing face of oncology development – is cancer still ‘different’? A US perspective

  • Artificial intelligence in drug discovery

  • October 2023 – Contents

  • Veterinary medicines: the challenges of new regulation

  • Transition to the new QRD template for veterinary medicines: challenges and opportunities

  • Autogenous vaccines under Regulation (EU) 2019/6

  • Prequalification of veterinary vaccines and medicines

  • EMA activities related to antiparasitic veterinary medicinal products

  • Optimal materials selection in medical device development – a proactive biocompatibility approach

  • December 2023 – Contents

  • Advancing global
    healthcare together

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

  • HM2: Improving the odds of regulatory success

  • PS1:
    Health technology assessment –
    the new EU regulation

  • VM1:
    Horizontal legislation and
    veterinary medicine availability

  • VM2: New initiatives in regulatory science

  • MD2/IVD2:
    Medical technologies −
    a catalyst for
    regulatory innovations

  • IVD3: IVDR: Current state

  • TOPRA Annual lecture

  • September 2023 – Contents

  • The worldwide web of regulation

  • Q&A:
    Navigating the
    pharmaceutical supply chain

  • Navigating the global supply of starting materials for cell-based therapies

  • Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry

  • Biosimilars CMC development considerations from the sponsor perspective

  • Warning letters for direct-to-consumer advertising: a five-year retrospective analysis

  • November 2023 – Contents

  • Editorial - November 2023

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

  • A harmonised approach to clinical data standards

  • Controlled substances development – past, present, and future

  • Access consortium: in the current submission transmission ecosystem

  • Transitioning from paper to electronic IFU for EU MDR 2017/745

  • Medical device standards update: November 2023

  • July/August 2023 – Contents

  • Equal access to medicines:
    finding the balance

  • African Medicines Agency and a new African regulatory ecosystem

  • EU versus Rest of the World regulatory frameworks and requirements for human tissue-based products

  • A year of clinical trials under IVDR:
    a sponsor’s perspective

  • Impact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)

  • Regulatory challenges and opportunities facing hearing aid manufacturers in Europe

  • A critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – Part 2

  • RegRapPod − July/August 2023

  • Australian PM makes thalidomide apology on 62nd anniversary

  • ICMRA regulators to mark its 10th year at event in Australia

  • European Parliament gives first stage approval for revised EMA fees

  • Northern Ireland deal permits GB medicines but not medical devices

  • UK set to accept CE mark for medical devices until 2028