05.12.21 Regulatory Submissions: How To Avoid Big Problems
CFO to the biopharma stars and frequent
Business of Biotech guest Allan Shaw shares the keys to efficiency as you move your candidate from the bench to the bedside. Shaw addresses the common perils of insular thinking in biopharma and offers practical advice for avoiding those pitfalls. Listen now and subscribe so you never miss an episode.
May Issue Articles
While business incubators are not uncommon, facilities such as these provide laboratory equipment and staff to manage safety, training, and other lab operations for entrepreneurs to reduce their initial investment expenses.
The EMA has published a guide to implementing ISO IDMP data standards that will have global repercussions. Remco Munnik has been working with the EU focus group, putting together the EU IDMP
How to transform life sciences experiences via improved information flow europeanpharmaceuticalreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from europeanpharmaceuticalreview.com Daily Mail and Mail on Sunday newspapers.
The IDMP data standards aim to standardise the submission of data on medicinal products. Remco Munnik, Associate Director at Iperion, has been working with the EU focus group creating the EU IDMP Implementation Guide version 2, published late February. He explains why pharma companies need to act now in response to the new guidance and provides practical recommendations for action.
The EU Identification of Medicinal Products (IDMP) Implementation Guide version 2.0 (EU IG), for the submission of data on medicinal products, sets out the implementation requirements of the ISO IDMP standards in the EU and triggers the countdown to the implementation of IDMP in Europe. With the clock ticking, life sciences companies doing business in the EU need to start getting their data in order and processes in place. In addition to the data requirements of ISO IDMP, the new Target Operating Model (TOM) implies that existing processes within life sciences companies need to be amended to collect more