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The European Union’s new Medical Device Regulation (MDR) will go into effect in May, 2021, and In Vitro Diagnostic Device Regulation (IVDR) in 2022.
Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks the flexibility, analytical power and efficiency to address today’s development demands. It is essential to develop a regulatory strategy plan early in drug development to identify key challenges that may arise, and interact collaboratively with regulatory authorities. This will also enable you to ensure that plan aligns with the profile and commercialisation for drug development.
Governments worldwide are swiftly intervening to create alliances with pharma, biotech, diagnostics and medical device manufactureres to address the COVID-19 threat. International regulatory agencies are considering accelerated approvals, including Emergency Use Authorisations.
To stay up to date with all COVID-19 related regulatory content, visit ICON's Coronavirus Observatory. This tool utilises powerful AI analysis and data visualisation for COVID-19 news and social media including regulatory updates.Coronavirus Observatory
Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help. Read the whitepaper for key factors to ensure that parallel consultation meetings are well prepared, productive and informative.Read the whitepaper
Read the "Getting Ready for Europe’s New Rules: A Guide for Successfully Developing and Commercialising Medical Devices and In-Vitro Diagnostics under MDR and IVDR" white paper to learn how to effectively prepare for these imminent regulatory changes.Read the whitepaper
This webinar will provide insight into regulatory developments in Taiwan, China, Singapore and Japan, delving deeper into the recent and upcoming safety regulations in Korea, to support understanding and compliance in pharmacovigilance. It will explore methods for keeping up to date with the latest regulatory intelligence, medical writing customisation and achieving operational efficiency through automation.Register for webinar
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety, written by Arinder Sihota and Trupti Gurjar, which featured in the March 2020 edition of Pharma Focus.Download article
The scope and complexity of this legislation will require significant changes in areas such as product development, data reporting, quality assurance and manufacturing processes. While these dates may seem a long way off, manufacturers need to start planning immediately, as adjusting will take time and effort.Access webinar recording
ICON’s Nuala Murphy and David Morse discuss trial pauses and clinical halts after three high-profile COVID-19 trials are temporarily halted as a result of potential safety issues being flagged by independent Data and Safety Monitoring Boards. Read more in this Biocentury article.Read article
ICON's Angela Brown considers what manufacturers can learn from medical device regulation (MDR) and the effect it will have on the in vitro diagnotic landscape (IVD).Download article
A thought leadership article on the approaching deadline for the new medical devices regulation (MDR) & in vitro diagnostic device regulation (IVDR).Read article
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published new guidance on how it will regulate medical devices starting in January 2021.
FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies.
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.
Many firsts as deadlines draw closer, yet bottleneck concerns remain.
The respiratory devices market is witnessing enormous demands across the globe, resulting from the increased need for ventilators due to rising COVID-19 cases.