28 episodes

The Brandwood CKC podcast provides monthly updates on pharmaceutical, medical device and IVD commercialisation helping you understand how to gain global market access.

Let's talk pharmaceutical, global medical devices + IVD regulatory services Brandwood CKC

    • Business
    • 5.0 • 2 Ratings

The Brandwood CKC podcast provides monthly updates on pharmaceutical, medical device and IVD commercialisation helping you understand how to gain global market access.

    Get Your Design In Control

    Get Your Design In Control

    In this webinar, we navigate you through the design control requirements of the main regulators. Discuss the design and development process for medical devices, including software. Share our experience and provide practical tips for implementation into your quality management system to produce reliable documentation which demonstrates regulatory and quality compliance.

    Criticality of Medical Device Risk Management for Patient and Product Safety

    Criticality of Medical Device Risk Management for Patient and Product Safety

    Regulatory bodies have emphasised the importance of Risk Management under ISO 14971 in the development of medical devices and in-vitro diagnostics. In this webinar, led by Senior Consultant, Yervant Chijian we explore how Risk Management is critical to regulatory frameworks and provide an overview of the fundamental principles and key standards.
    In addition, best practices for implementing risk management activities within your organisation including post-market considerations will be discussed and outlined.
    Presenter: Yervant Chijian, Brandwood CKC

    • 37 min
    Innovative Product Regulatory Strategies and Considerations for Medical Devices and IVDs

    Innovative Product Regulatory Strategies and Considerations for Medical Devices and IVDs

    As the global medical practice undergoes drastic change embracing faster access to innovative technologies, getting the regulatory strategy right from the onset can mean the difference between success and failure.

    • 46 min
    Sponsorship in Australia and New Zealand - What devices manufacturers and local representatives need to know.

    Sponsorship in Australia and New Zealand - What devices manufacturers and local representatives need to know.

    Medical device and IVD manufacturers who wish to distribute their products in Australia and New Zealand need to appoint a local sponsor. In this webinar, Brandwood CKC Consultant, Orsola Regaglia, covers the key requirements of Sponsors for TGA and MedSafe, their role in the premarket and postmarket phases. We provide key recommendations for manufacturers and sponsors on how to select the right partner and effectively interacting between the main entities and the Regulators.
    Presenter: Orsola Regaglia, Brandwood CKC

    • 37 min
    FDA Guidances in 2020: A high-level pharma, device and diagnostic overview

    FDA Guidances in 2020: A high-level pharma, device and diagnostic overview

    2020 was a year like no other and COVID-19 has certainly challenged the Pharmaceutical, Medical Device and Diagnostic Industries. Even with all that was going on with COVID-19 and making COVID-19-related medical products available, 2020 was a banner year for guidances issued by the US Food and Drug Administration (FDA). In this month's webinar, our Directors, Rob Stringer and Terrance Thiel will discuss those guidances that have the most impact on the pharma, medical device and diagnostic products, by providing an overview, understanding and examples of these guidances' effects, including the potential effects to other regulatory jurisdictions. Please join us for this February webinar and feel free to ask any FDA guidance questions in advance.
    Presenters: Robert Stringer and TJ Thiel, Brandwood CKC

    • 44 min
    RAPS Webcast recording: Global Medical Device and IVD Regulatory Changes in 2020 and Their Impact to Asia Pacific

    RAPS Webcast recording: Global Medical Device and IVD Regulatory Changes in 2020 and Their Impact to Asia Pacific

    This webcast recording reviews the most salient global regulatory changes in 2020 for Medical Devices and Diagnostics and how they impact the Asia Pacific. Brandwood CKC's TJ Thiel and John Lockwood of Pearl Pathways, delve into the major regulatory bodies' most important regulatory changes and analyse the potential impacts on the Asia Pacific. There is also a focus on changes in Australia's TGA, Japan's PMDA, and China's NMPA. Additionally, this presentation takes into account the impact the COVID-19 pandemic has had and how regulators have adapted regulatory changes to meet medical supply demand. The presentation and Q&A were pre-recorded during a RAPS (Regulatory Affairs Professional Society) US Chapter program.

    • 1 hr 15 min

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