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International Clinical Trials

Adding Intelligence to Integration



Keeping on top of regulatory requirements in life science is a full-time occupation, as the landscape is in a constant state of flux. The new demands each year are considerable, and 2021 will be no exception. It was already set to be a big year for new compliance deadlines, and now the continuing COVID-19 pandemic is driving new urgency around streamlining and accelerating processes and shoring up data quality.

In the EU, Identification of Medicinal Products (IDMP) data-based marketing authorisation submissions are compulsory as of January 2021 for centralised procedures, and the new Medical Devices Regulation will fully apply in EU member states from late May. Brexit is having an impact on the supply of medicines and medical devices in and out of the UK. The Eurasian Economic Union is working towards unified quality control of medicines. The US, Canada, and China are continuing to make their own strides towards standardised electronic submissions and data exchange, as well as improved product traceability, as part of a global effort to ensure safer and more timely access to all kinds of medical treatments.

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About the Author

Romuald Braun is Vice President of Strategy for Life Sciences at Amplexor. He holds a Master’s degree in Drug Regulatory Affairs, an Engineers’ diploma in Data Technology, and has spent the last 26 years working in compliance, document management, and content management related roles in this industry spanning client-based as well as consulting and project management roles.

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