Calendar of Events
News from EIPG
- EIPG Comments on Two EMA Papers for Consultation
- european Industrial Pharmacy Issue 34 published
- EIPG feedback on draft guideline for notification of serious breaches in clinical trials
- EIPG Request for Comments on EMA Draft Guideline
- EIPG comments on latest Eurostat statistics on international trade in medicinal and pharmaceutical products
- Risk assessment requirements to control elemental impurities in veterinary medicinal products October 17, 2017
- Post-complete response letter meetings between FDA and ANDA applicants Under GDUFA October 17, 2017
- Supplementary protection certificates (SPCs) and patent research exemptions October 15, 2017
- Use of extrapolation in the development of medicines for paediatrics October 15, 2017
- Determining whether to submit an ANDA or a 505(b)(2) application October 15, 2017
Tweets by @EIPGeu
Transport of health care products under controlled temperatures
The Conseil Central B of the Ordre National des Pharmaciens has published its “Recommendations concerning the transport of health care products under controlled temperature (5°C +/- 3°C)”. An English translation of the document is available on the EIPG website.
EIPG Guidelines on Good Distribution Practices of Medicinal Products
The General Assembly of the European Industrial Pharmacists Group held in Riga on the 18th of April 2009 discussed draft guidelines on GDP of medicinal products. The final document was first released in 2009, and subsequently updated in 2010 to reflect changes in the WHO guide to good distribution practices.
EIPG Guide to Continuous Professional Development for Regulatory Affairs
The General Assembly of the European Industrial Pharmacists Group held in Riga on the 18th of April 2009 discussed draft guidelines on CPD for Regulatory Affairs prepared by Regulatory Affairs members from France, Germany and Britain. The final document has been released.
Guide to Good Regulatory Practice
The General Assembly of the European Industrial Pharmacists Group held in Malta on 18th of April 2008 ratified the publication of an updated Guide to Good Regulatory Practice.
EIPG Guidance on Continuing Professional Development for Qualified Persons
During the 2007 General Assembly in Prague, the Working Group on Qualified Person matters presented the final version of a document regarding Guidance on Continuing Professional Development for Qualified Persons. The document was approved by the General Assembly, and is proposed by EIPG as a guide for all Qualified Persons, Technical Directors and other Responsible Persons.