17 episodes

The Brandwood CKC podcast provides monthly updates on medical device or IVD commercialization helping you understand how to gain global market access.

Let's talk global medical device + IVD regulatory services Brandwood CKC

    • Business
    • 5.0, 2 Ratings

The Brandwood CKC podcast provides monthly updates on medical device or IVD commercialization helping you understand how to gain global market access.

    Let's talk clinical evidence reports - what you need to know.

    Let's talk clinical evidence reports - what you need to know.

    As regulators around the world look more closely at the Clinical Evaluation Report in support of a device's safety and efficacy, we revisit the key aspects of discussion on which manufacturers and sponsors should focus their efforts.

    Listen in to hear Heyam Kalla provide guidance in navigating the world of CERs that meet regulatory expectations, including those that may not be expressly written into the guidance.

    Presenter: Heyam Kalla, Senior Consultant, Brandwood CKC

    • 28 min
    Faster Australian Medicine Approvals through Leveraging International Evaluations

    Faster Australian Medicine Approvals through Leveraging International Evaluations

    The Australian Therapeutic Goods Administration recently implemented several new initiatives that enable sponsors to utilise regulatory approvals from other jurisdictions (e.g. USA, Canada, Europe) to accelerate prescription medicine approval in Australia. This webinar outlines how these processes work, what criteria are applied, and the corresponding impact on regulatory timelines - a must-listen for those seeking Australian approvals for Prescription Medicines, Biological Medicines, Generics and Biosimilars in this presentation.

    Presenter: Robert Stringer, Director and Principal Consultant, Brandwood CKC

    • 20 min
    Emergency approvals - moving things along in a Pandemic

    Emergency approvals - moving things along in a Pandemic

    With disrupted supply chains, shortages of medicines, masks, ventilators and test kits, everyone wants the regulator's attention - right now, today. The good news is that pandemic planning has been a thing for regulators for many years. And they have the powers and the laws to do things differently. From expedited reviews to waivers of change applications to emergency supply approvals without product registrations, it all becomes possible. Regulators still expect to see some sort of evidence of safety and efficacy though it may be much more flexibly interpreted.
    Do you want to get a medical device or medicine approved quickly in response to COVID-19? Hear from Arthur Brandwood and Robert Stringer as they discuss how Australia's TGA has become fleet of foot in these troubled times.

    • 39 min
    Biocompatibility - Chemistry takes over from biology and cell cultures replace laboratory animals

    Biocompatibility - Chemistry takes over from biology and cell cultures replace laboratory animals

    As the ISO Technical Committee 194 prepares to meet later this year, we look at the planned changes to the standards, the rising prominence of chemical characterisation and the efforts to eliminate animal testing.

    Join James Morrison and Jean Boudaud to learn what's hot in ISO 10993 biocompatibility evaluation.

    • 29 min
    Nobody Complained! Post market reporting under MDR.

    Nobody Complained! Post market reporting under MDR.

    With just a few months to go to the MDR transition deadline, manufacturers will be subject to a raft of new formal postmarket reporting requirements. And they all rely on active data collection. Inadequate monitoring leaves a manufacturer defenceless in the event of a product failure.

    Join Belinda Dowsett and Heyam Kalla to learn how good postmarket and QA processes are the keys to disaster prevention.

    • 21 min
    Harmonization - the Triumphs and the Tragedies

    Harmonization - the Triumphs and the Tragedies

    Learn how Australia does faster drug approvals through shared evaluations and leveraging international approvals. How to minimise risks from the European MDR devices train wreck and the growing trend for "Reliance" as CE mark becomes harder and rarer. And why global drug shortages mean you should be careful what you eat in the holiday season. Join Arthur Brandwood and Nancy Stringer to learn what to watch out for and how to manage your risks in 2020.

    • 30 min

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