Archives

Annex 1 – a focus on its main issues (Webinar)

September 12th, 2020 (No Comments)

EIPG and Tecniche Nuove’s next webinar, presented by Dr Francesco Bosci, summarizes the most relevant comments to the V12 draft document of Annex 1 (appendix of Eudralex Vol. 4 EU GMP) as developed by the EIPG national working groups and delivered to EC for consideration for the preparation of the final Annex to be published. […]

How a pandemic has affected the pharma industry (Webinar)

September 12th, 2020 (No Comments)

In EIPG’s and PIER’s next webinar, Dr Sheuli Porkess will review the changes in the way research is being undertaken as a result of COVID with the current extraordinary collaboration between industry, academia, charities, foundations and public-private partnerships, and contemplate whether these changes are likely to continue in a highly competitive industry. She will discuss […]

EIPG publishes updated version of Code of Practice for Qualified Persons

August 30th, 2020 (No Comments)

The EIPG Code of Practice for Qualified Persons has been conceived with the aim of offering an updated view of the legal and technical requirements pertaining to the position of the Qualified Person (QP) in Europe. The added value of this document is represented by the comments and recommendations which have been added to each […]

Consultation on Annex 21: Importation of medicinal products, of the EudraLex Volume 4 (Webinar)

July 24th, 2020 (No Comments)

EIPG’s and PIER’s next webinar, presented by Stan O’Neill, will address the European Commission’s has targeted stakeholders’ consultation on the draft Annex 21: Importation of medicinal products, of the EudraLex Volume 4. This new Annex, in which the Qualified Person (QP) has a key role, and which has been under discussion for a long time, […]

The role of the body clock in drug development, efficacy and toxicity (Webinar)

January 29th, 2020 (No Comments)

EIPG’s and PIER’s next webinar, presented by Dr Annie Curtis, will cover the role of the body clock in drug development, efficacy and toxicity. For centuries we have known that rhythms in our physiology exist so that our bodies stay in tune with the daily cycle, imposed by the rotation of the Earth. Twenty years […]

Medicines shortages: root causes and potential solutions

December 7th, 2019 (No Comments)

Medicines shortages are a significant cause of concern for patients, clinicians and our public health. They impact on patients’ health outcomes by causing delays in treatment or forcing changes in treatment regimes as well as inducing a great deal of stress and worry to patients and their families. The European associations representing manufacturers of vaccines […]

GMP documentation management: requirements and best practices (Webinar)

October 19th, 2019 (No Comments)

EIPG’s and PIER’s next webinar, presented by Alessandro Regola, will cover the GMP requirements and the practical implementation of a management system for quality related documentation. After an introduction referencing the relevant GMP norms and guidances, the different types of documents will be described with their function in the Quality System and their requirements. Paper […]