Pharma manufacturers are faced with mounting costs and liability concerns in the face of a fractured (and growing) landscape of drug take-back regulation. Inmar mitigates legislative and financial risk with a full-service drug take-back program built for efficiency.
Inmar’s RxT DSCSA cloud-based subscription platform allows users to be in full compliance with the Drug Supply Chain Security Act. This regulation was enacted in 2013 as a ten-year phase in regulation as an effort to minimize the threat of suspect and counterfeit drug products entering the US supply chain.
This ninth edition of Fundamentals of EU Regulatory Affairs focuses on the significant transformation of the healthcare product regulatory landscape in the European Union (EU), including the impact of Brexit and the European Medicines Agency’s (EMA) move from London to Amsterdam.
This book provides a “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices, including discussions on the development and implementation of global regulatory strategies for medical devices, labeling, clinical, risk management, marketing and postmarketing.
The R&Q EU MDR expert team has developed a PMCF survey process that is holistic and flexible around medical device manufacturers’ needs as part of an “end-to-end” PMS solution, including the critical task of managing NB expectations. R&Q’s holistic approach is based on inter-dependent processes of Risk Management, Clinical evaluation and Post Market Surveillance. In particular the approach includes identifying gaps from CER’s and residual risks (from risk management), development of a PMCF strategy taking into account considerations for products that currently bear the CE mark per MDCG 2020-6, and creating a PMCF plan per MDCG 2020-7 that is aligned with a PMCF survey. Based on a calculated sample size, the survey is deployed with subsequent data held in a compliant EDC platform with an integrated statistical package used for the data analysis and a PMCF report is created per MDCG 2020-8.
Throughout the clinical development process, interactions with the regulatory authorities are strongly encouraged but the response timelines are often prohibitive and clinical development teams tend to stick to the strict minimum. We’ve captured thousands of sponsor-FDA exchanges made accessible to you through a simple but smart search tool to help you better understand the agency’s expectations, prepare for scheduled meetings and optimize your clinical development strategy.
Designed as a reference guide, the book is broken into sections that can be quickly navigated through, giving reference to the original EU IVDR text and what requirements must be met. It does not replace the EU IVDR text, which should be used in conjunction with this guidebook.