webinar Archives - European Industrial Pharmacists Group (EIPG)

The European Medicines Regulatory Network Data Standardisation Strategy


by Giuliana Miglierini The availability of interoperable data is a “must” to ensure the smooth sharing, use and re-use of data along the entire regulatory process. A new document - the European Medicines Regulatory Network Data Standardisation Strategy - has Read more

ICMRA published a Reflection paper on remote inspections


by Giuliana Miglierini Remote inspections have become a widely used approach since the last two years to ensure the oversight of the compliance of pharmaceutical productions to regulatory requirements, as the prolonged lockdown periods determined by the pandemic made very Read more

EMA’s Q&A on the integration of EudraGMDP and OMS


by Giuliana Miglierini A new step in the integration at the central level of data needed to manage regulatory procedures is going to be activated on 28 January 2022: starting from this date, member states’ national competent authorities (NCAs) shall Read more

Webinar: Antimicrobial Resistance – How do we make Antibiotics Economically Viable again?

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Our first EIPG Webinar of 2022 will be held in conjunction with PIER and University College Cork on Tuesday 18th January 2022 (17:00 CET). It is entitled: «Antimicrobial Resistance – How do we make Antibiotics Economically Viable again? ».

Our speaker is Professor Philip Howard, a hospital pharmacist who is the immediate past President of the British Society of Antimicrobial Chemotherapy. He is a member of the UK Department of Health’s advisory group on Antimicrobial Resistance & Healthcare Associated Infections and the NICE Common infections guidelines group, NICE living CoVID guidelines group and the NICE New models of antimicrobial funding committee. He is a spokesman for the Royal Pharmaceutical Society on Antimicrobials and for the Antibiotic-Action and British Society of Antimicrobial Chemotherapy charities. The webinar chairman is Dr Luigi Martini former Chief Scientist at the Royal Pharmaceutical Society.

Antibiotic sales during the golden era of antibiotic discovery of the 1960s and 1970s outstripped most other therapeutic areas. As soon as antimicrobial resistance became an issue, there was a focus on using them more prudently. Antimicrobial resistance (AMR) in the high-income countries is driven by over-consumption, so antimicrobial stewardship initiatives to avoid starting or stopping or de-escalating antibiotics as soon as possible have seen diagnostic scoring systems or point of care tests flourish. Other challenges seen are the lack of transparency in the supply chain, coupled with low prices and these have made antimicrobial shortages common. New antimicrobials are needed to combat AMR. The pharmaceutical industry should be able to play an important role in antimicrobial stewardship whilst still marketing economically viable new products.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


IMP manufacturing in the era of the clinical trial regulation 536/14

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The next EIPG’s and PIER’s webinar to be held on Thursday 18th November 2021 (17.00 CET) will be chaired and the subject introduced by Irene Gonzales-Conde, Board Member of AEFI (Spanish Association of Industrial Pharmacists).

The main speaker, Luciano Gambini has spent most of his working life in global R&D quality assurance, setting up internal policies for the quality of Investigational Medicinal Products (IMPs). He is the coordinator of the AFI (Italian Association of Industrial Pharmacists) working group on manufacture of IMPs.

There has been extensive debate about the Clinical Trial Regulation which finally enters into force on 31st January 2022. However, little has been discussed about manufacture of the IMPs. The aim of this webinar is to raise questions and provide preliminary answers to any differences between the current and new manufacturing and labelling requirements.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


Webinar: PBPK Modelling and Simulation – A valuable tool for Pharmaceutical Development

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Over the last 20 years Physiologically – Based Pharmacokinetic (PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry. Its adoption has been driven by the availability of commercial software platforms and a realisation of the benefits to be gained including the potential to reduce the number of in vivo studies performed. 

In EIPG’s and PIER’s next webinar, to be held on 21st October 2021 (17.00 CEST), Jonathan Brown will cover an introduction to PBPK modelling, what it is and how it can be applied to support Chemistry, Manufacturing and Controls (CMC) development. It will provide an overview of usage in oral, small molecule development, supported by examples from the areas of biopharmaceutics and formulation development. Current and potential future applications of PBPK modelling in Quality and Regulatory fields will also be discussed.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.