Vivek Tomar

Senior Director, Regulatory Affairs, Global Regulatory Affairs Solutions, Syneos Health, India.

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    Journal

    EU MDR implementation – what is changing for the medical device industry?

    2024-02-08T00:05:00

    This article focuses on the impact of the Medical Device Regulation (MDR) transition extension period and provides guidance for medical device manufacturers on the new Regulation (EU) 2023/607. MDR (EU) 2017/745 came into force in May 2017 and became applicable in May 2020. After multiple amendments to the MDR, the ...

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    Journal

    Cell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies

    2024-01-05T00:05:00

    Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...

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    Journal

    Biosimilars CMC development considerations from the sponsor perspective

    2023-09-01T00:05:00

    Sponsors face significant challenges in the development of biosimilars, particularly in the chemistry, manufacturing, and controls (CMC) aspects. Key areas of biosimilar CMC development include establishing a reliable and consistent manufacturing process, controlling critical quality attributes, and developing analytical methods to assess product quality. Furthermore, sponsors must conduct extensive characterisation studies, encompassing physicochemical and functional assays, to demonstrate biosimilarity between the biosimilar and the reference medicinal product (RMP). This article provides insights from a sponsor’s perspective, highlighting the challenges and opportunities associated with the biosimilar CMC development process. By adhering to these recommendations, sponsors can navigate the complexities of biosimilar development and enhance the likelihood of successful outcomes.

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    Focus

    Practical insights into the recent EU MDR framework

    2022-04-18T13:18:00

    This article focuses on the impact of the new guidance document on drug-device combination (DDC) products, in Article 117 of the European Medical Device Regulation (MDR) for pharmaceutical marketing authorisation holders (MAHs). It explores the new role of the notified body (NB) versus the MAH pertaining to the device part of the DDC, some of the pitfalls encountered by pharmaceutical MAHs and potential solutions to efficiently navigate the new framework. It also provides practical insights into key technical requirements for the product-specific quality aspects of a medical device, which are within the quality dossier of a successful EU application. The article also explores efficient global implementation within fast evolving and at times divergent, regional regulations.