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The European Union’s new Medical Device Regulation (MDR) came info effect in May, 2021, and In Vitro Diagnostic Device Regulation (IVDR) will take effect 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.
For sponsors preparing to meet short deadlines for PLS submission, this whitepaper outlines considerations such as creating compliant templates, endpoint consistency and inclusion, and health literacy.Read the whitepaper
Read the whitepaper to learn about current clinical trial disclosure (CTD) requirements, future regulatory changes, and strategies for planning for disclosure.Read the whitepaper
Sponsors preparing to share their clinical documents can incorporate best practices and implementation recommendations presented in this whitepaper, including considerations for planning and basic data anonymisation strategies for protecting patient privacy while balancing data utility.Read the whitepaper
The RACE Act requires that studies and investigations involving products that treat adult cancer must also assess the use of those products in children.
In this whitepaper, our experts examine: Key success factors for companies, challenges presented by the RACE act, and successes through collaboration.Read the whitepaper
Ensuring regulatory compliance with the PSMF
It is essential that those who hold Marketing Authorisations (MA) within the European Economic Area have an established Pharmacovigilance System Master File (PSMF), which should be ready at the time of submission of all new applications for MAs. This whitepaper assesses the effectiveness of a global PSMF and its benefits to study personnel.Read the whitepaper
How careful preparation of the initial PBRER sets up future success
The International Conference of Harmonization ICH-E2C (R2) requires all license holders of new medicinal products to submit a Periodic Benefit-Risk Evaluation Report (PBRER). Gain insight about best practices that can be implemented during the process of creating an initial PBRER.Read the whitepaper
China’s regulatory reforms have attracted many foreign companies to conduct clinical trials and register their medicinal products in China. However, the evolving regulatory environment and country-specific requirements present significant challenges.Read the whitepaper
What companies must consider when developing an asset and the importance of regulatory strategy
Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner.Read the whitepaper
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
The European Union’s new Medical Device Regulation (MDR) came into effect on 26 May, 2021, and In Vitro Diagnostic Device Regulation (IVDR) will come into effect one year later. These new directives will bring:
Stay current on country, regional and global regulatory changes with ICON’s monthly Regulatory Intelligence Newsletter. It will keep you up to date with global regulatory changes that could impact your product.
Our experts review, interpret and summarise the latest regulatory developments so that you can spend more time taking your product to market.Subscribe to receive newsletter
The impact of Brexit on the regulatory body, NICE, including NICE’s strong influence on the European market.
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety.
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.
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).
The key challenges associated with the new EU MDR and IVDR in this article in Med-Tech Innovation News.
A thought leadership article on the approaching deadline for the new medical devices regulation (MDR) & in vitro diagnostic device regulation (IVDR).
As of 15 December 2021, the European Parliament and the European Council have adopted their proposal to make the suggested progressive IVDR rollout timeline official.
Discover why identifying the study objective during the planning process for PMCF studies is a critical step in the transition to MDR.
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.
Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
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.
To ensure compliance under MDR and IVDR, manufacturers should act quickly to identify and secure a notified body (NB). Manufacturers should evaluate expertise and resources to determine which NBs are the best fit for their products
The respiratory devices market is witnessing enormous demands across the globe, resulting from the increased need for ventilators due to rising COVID-19 cases.