We wonder how many businesses and individuals working with ATMPs (Advanced Therapy Medicinal Products) are aware of the EC EudraLex…
This is essential reading for anyone working in Pharma: https://www.picscheme.org/en/publications
We have moved our office to: NBV Enterprise Centre David Lane Nottingham NG6 0JU Please send any correspondence to this…
Strongly urge anyone working in pharma to compare these reports. Very revealing as a measure of change in the industry,…
A new GAMP GPG is out: https://ispe.org/publications/guidance-documents/gamp-good-practice-guide-data-integrity-manufacturing-records?_hsenc=p2ANqtz-8-LZkhGGrGTtpyLzFujT90hbP1DdlPsqU8p5peNR8lovVANe4elNnkKCAAFu5QiR9Zf3JKPYDrPSKBmi1e3k4vA4twrdqNMKiqhvIeUwqx4wfvK9c&_hsmi=72998932
Interesting to read this again a year after publication. https://www.parliament.uk/business/committees/committees-a-z/commons-select/business-energy-industrial-strategy/inquiries/parliament-2017/inquiry4/?fbclid=IwAR2vEjiWe23iWS8kGV25kRtC8SPZXEDWugDGg_4WSatHXtgtk7bogwG6pd4
– Guidance on centrally authorised products.
– Industry survey (for centrally authorised products).
– Guidance on nationally authorised products
Drug development can be quite a risky business at the best of times, but particularly in the biotech sector where companies may only have a few assets to their name.