GMP News Drug Safety/Pharmacovigilance

16.01.19

New ISO Standard for Tamper-Evident Packaging

The International Organization for Standardization has published the new ISO standard "Packaging - Tamper verification features for medicinal product packaging".

more

04.10.18

EMA clarification on the download of SARs from EudraVigilance

Due to inquiries concerning the handling of ICRs in EudraVigilance, the EMA has published a brief and structured clarification.

more

04.10.18

What to expect from GVP inspections?

The MHRA recently updated their Good Pharmacovigilance Practice (GVP) webpage on the MHRA website. In addition, the agency provided important things to know about GVP inspectors and GVP inspections.

more

04.10.18

Pharmacovigilance: Be prepared for "Hard Brexit"

The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).

more

22.08.18

EMA publishes list of contact details for pharmacovigilance enquiries

The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.

more

11.07.18

FDA Drafts on Shared System REMS

The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.

more

13.06.18

FDA opens Docket on Software Products

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

more

24.01.18

PSURs: EMA revises Post-Authorization Procedural Advice

The EMA recently revised its post-authorization procedural advice for users of the centralized procedure. Read more about new and revised Q&A´s concerning Periodic Safety Update Reports (PSURs).  

more

06.12.17

Drug Safety: FDA´s new Draft Guidance Regarding REMS

The FDA recently published its new draft guidance on Risk Evaluation and Mitigation Strategy (REMS). Read more about Format and Content of a REMS Document.

more

22.11.17

GVP Update 2017

There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics