European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

Documentation 87

Documentation Communication 87

pharmaphorum

AUGUST 30, 2022

The importance of patient and public involvement and engagement (PPIE) has been well documented, but there has, to date, been a lack of practical advice on how to implement and manage meaningful processes. . The result was the EnACT (engage, acknowledge, communicate, and trust and transparency) principles, as set out in the guide: .

Communication 83

Communication Documentation 83

pharmaphorum

FEBRUARY 2, 2022

Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. But we need to evaluate for the gains we hope for, as well as for any unintended consequences.”. A practical consensus. Everything has moved so quickly.

Documentation 52

Documentation Packaging Communication 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? 2021 Workshop Report–Digital Technologies for Clinical Evidence Generation.”

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? 2021 Workshop Report–Digital Technologies for Clinical Evidence Generation.”

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. and management communication strategy. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™,

Documentation 98

Documentation FDA Labelling Communication 98

ISPE

JULY 5, 2023

CDER funded the National Academies of Sciences, Engineering, and Medicine (NASEM) to host a series of workshops that resulted in a consensus study report “Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, Recommendations.” FDA/M-CERSI Co-Processed API Workshop Proceedings.”

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52