spacer
home > ict > spring 2021 > adding intelligence to integration
PUBLICATIONS
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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.

Print this page
Send to a friend
Privacy statement
News and Press Releases

Nemera to build state-of-the-art manufacturing facility in Poland to serve more customers and patients

Based in Szczecin, this facility extends Nemera’s manufacturing capabilities and will bring more drug delivery device solutions to patients. Following the dynamic growth of the drug delivery devices market, as a world leader, Nemera is thrilled to extend its manufacturing capabilities in Poland.
More info >>

White Papers

Characterisation of Biopharmaceutical Proteins

Reading Scientific Services Ltd (RSSL)

Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the protein�s primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement