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Brandwood CKC
Australia
Приєднався 16 чер 2015
PharmaLex is a leading provider of specialized services for the pharmaceutical, biotech and MedTech industries. We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-enabled solutions to support you through the entire product lifecycle. We deliver exceptional results - going above and beyond the standard to deliver tailor-made solutions worldwide.
Get Your Device In Control June 2021
In this webinar, we navigate you through the design control requirements of the main regulators. We discuss the design and development process for medical devices, including software. And we share practical tips for implementation into your quality management system to produce reliable documentation which demonstrates regulatory and quality compliance.
Переглядів: 255
Відео
Criticality of Medical Device Risk Management for Patient and Product Safety
Переглядів 1,3 тис.3 роки тому
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, Brandwood CKC explores 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 ...
Innovative Product Regulatory Strategies and Considerations for Medical Devices and IVDs
Переглядів 6483 роки тому
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. In this webinar, we discuss the key considerations for registering innovative products and changes to existing products incorporating innovative modifications. We will focus on the cu...
Medical Device Sponsorship Requirements for Australia and New Zealand
Переглядів 8023 роки тому
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, we cover the key requirements of Sponsors for TGA and MedSafe, their role in the premarket and postmarket phases. We will provide key recommendations for manufacturers and sponsors on how to select the right partner and effectively interacting...
FDA Guidances in 2020: A high-level pharma, device and diagnostic overview
Переглядів 1943 роки тому
2020 was a banner year for guidances' issued by the US Food and Drug Administration (FDA). Brandwood CKC 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 juris...
Global Medical Device and IVD Regulatory Changes in 2020 and Their Impact to Asia Pacific.
Переглядів 5414 роки тому
This RAPS 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...
Top FAQs for 2020
Переглядів 1254 роки тому
2020 has been a year like no other and COVID-19 has certainly challenged the Medical Devices Industry. In this month’s webinar Grant Bennett and T.J. Thiel will discuss the most frequently asked regulatory questions for medical devices and diagnostics in this 2020 year-end review.
Hitting the Accelerator October 2020 Webinar
Переглядів 724 роки тому
In recent times, the TGA has introduced a range of new prescription medicine application pathways that utilise overseas evaluations and accelerate market access. The team at Brandwood CKC have extensive experience with these new pathways and this webinar will outline the latest developments and provide insights as to the pros and cons of each pathway. A must for companies looking to accelerate ...
Medical Device Regulations Under COVID-19. What you need to know.
Переглядів 2614 роки тому
COVID-19 has challenged the health systems’ dynamics in many ways and industry and regulators have responded by implementing special actions to ensure patients and caregivers are provided with adequate diagnostics, therapies, and protective equipment. In this webinar, Orsola Regaglia and Jean Boudaud will present an overview of the response to COVID-19 from the regulators in key geographies. We...
Blood, Sweat and Tears - An Update to In Vitro Diagnostics Regulatory Requirements World Wide
Переглядів 3374 роки тому
This webinar will provide an update to our 2019 webinar on In Vitro Diagnostic products, as well as current situations in the USA, Australia and other key geographies. Join T.J. Thiel for this discussion on recent regulatory changes and how businesses can best prepare for upcoming regulatory submissions for IVDs.
Medical Device Software: Current Developments in the Regulatory World
Переглядів 3,7 тис.4 роки тому
This webinar will provide an update to our 2019 webinar on Software as a Medical Device (SaMD) and Software in Medical Devices. Yervant Chijian will highlight recent regulatory changes as they apply to Medical Device software and how businesses can best prepare for upcoming regulatory submissions. Presenter: Yervant Chijian, Senior Consultant
Clinical Evaluation Report Webinar June 2020
Переглядів 2,5 тис.4 роки тому
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...
Keeping it clean: Regulation of Hand Sanitisers as Cosmetics or Therapeutic Goods
Переглядів 204 роки тому
The COVID-19 pandemic has seen a marked increase in the production of hand sanitisers. Depending on the composition, intended use and any claims made in relation to their use, hand sanitisers may be regulated as therapeutic goods that must be approved by the TGA before they can be supplied or are excluded from TGA regulation and do not require approval when they meet specific requirements or ar...
Faster Australian Medicine Approvals by Leveraging International Evaluations - May 2020
Переглядів 1124 роки тому
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-lis...
Latest Update on Ventilators_April Webinar
Переглядів 764 роки тому
Latest Update on Ventilators_April Webinar
Emergency approvals - moving things along in a Pandemic
Переглядів 1604 роки тому
Emergency approvals - moving things along in a Pandemic
Nobody Complained! Post market reporting under MDR
Переглядів 4,5 тис.4 роки тому
Nobody Complained! Post market reporting under MDR
Harmonisation - Triumphs and Tragedies
Переглядів 1085 років тому
Harmonisation - Triumphs and Tragedies
Documentation Deconstructed - Understanding Risk Management
Переглядів 4785 років тому
Documentation Deconstructed - Understanding Risk Management
Documentation Deconstructed: Understanding the Technical file
Переглядів 9 тис.5 років тому
Documentation Deconstructed: Understanding the Technical file
How to survive the Perfect Storm - International Harmonization and Lessons from Brexit and the MDR
Переглядів 1925 років тому
How to survive the Perfect Storm - International Harmonization and Lessons from Brexit and the MDR
A Bulletproof Clinical Evaluation Report: Making them stand up to regulatory scrutiny
Переглядів 6 тис.5 років тому
A Bulletproof Clinical Evaluation Report: Making them stand up to regulatory scrutiny
Making American Guidance Understandable Again
Переглядів 1166 років тому
Making American Guidance Understandable Again
Why MDSAP opens a world of opportunity.
Переглядів 4456 років тому
Why MDSAP opens a world of opportunity.
FDA and ISO stars aligning on ISO 10993
Переглядів 5736 років тому
FDA and ISO stars aligning on ISO 10993
Taking a 510k Down Under…leveraging US and Canadian and Japanese approvals for TGA registration
Переглядів 2996 років тому
Taking a 510k Down Under…leveraging US and Canadian and Japanese approvals for TGA registration
HVT: US ☆PVBC : US PDBAX : US AVGO : US Nobel prize 3FNG-FR : FR AZ : US
Great video!! Very clear and assertive. Thanks
Thank you for posting!
Hi. Thank you so much for this video, super insightful. If the company is not claiming for equivalence AND they don't have post-market data, should we still include a discussion on post-market data for an equivalent device in our SOTA?
Hi.. this is very helpful. I have a question - For demonstrating substantial equivalence can we consider devices with different materials such as in Titanium versus Polymer. Both are biocompatible and achieve same intended purpose, but through a different material. Will it be accepted by TGA? Thanks!
Just my two cents, you will need to demonstrate the equivalence in biological (through biocompatibility test and/or chemical characterization test), mechanical (mechanical testing), and some other relevant tests (e.g., does it carry cellular or animal components?) between these two materials to show that they are equivalent in safety and performance for the intended purpose.