webinar Archives - European Industrial Pharmacists Group (EIPG)

Approval of the Data Governance Act, and EMA’s consultation on the protection of personal data in the CTIS


by Giuliana Miglierini The Data Governance Act (DGA) was approved and adopted in May 2022 by the European Council, following the positive position of the EU Parliament; the new legislation will entry into force after being signed by the presidents Read more

The transition towards EMA's new Digital Application Dataset Integration (DADI) user interface


by Giuliana Miglierini The Digital Application Dataset Integration (DADI) network project is aimed to replace the current PDF-based electronic applications forms (eAFs) used for regulatory submissions with new web-forms accessible through the DADI user interface. The European Medicines Agency (EMA) has Read more

IVD regulation in force: new MDCG guidelines and criticalities for innovation in diagnostics


by Giuliana Miglierini The new regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) entered into force on 26 May 2022. The new rules define a completely renewed framework for the development, validation and use of these important Read more

Webinar: Implications and Opportunities of ICHQ2(R2) and ICHQ14

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The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 15th June 2022 (17.00 CEST), on the implications and opportunities of the revision of ICHQ2 (on validation of analytical procedures) and the ICHQ14 (on analytical procedure development). Our speaker Phil Borman, Director and Senior Fellow at GlaxoSmithKline, pioneered the adaptation of Quality by Design principles to analytical procedures and currently co-leads the EFPIA ICH Q2(R2) and ICH Q14 guidance on Quality by Design, will explain why these guidelines are being developed and will highlight their implications and opportunities.

The revision of ICHQ2(R1): Validation of Analytical Procedures and the development of ICHQ14: Analytical Procedure Development reached the key ICH milestone of Step 2 publication for public consultation in March 2022. The combined topic Q2(R2)/Q14 represents an opportunity to provide guidance on how to apply enhanced development approaches (‘Quality by Design’) to analytical procedures and how to use the knowledge obtained to support routine use of procedures. Q2(R2)/Q14 will also have the potential to facilitate the selection or identification of development approaches that will reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical product Lifecycle Management. This webinar will explain why these guidelines are being developed as well as highlighting the implications and opportunities.

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


Continuous Manufacturing of Pharmaceuticals: Higher Quality, Greater Flexibility

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The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 30th March 2022 (17.00 CEST), on Continuous Manufacturing of Pharmaceuticals. Giustino Di Pretoro a subject matter expert and drug product development lead will provide his expert practical experience of continuous manufacturing. Our speaker is Giustino Di Pretoro the Scientific Director at Janssen Pharmaceutica, a Johnson & Johnson Company. He is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field.

For more than 50 years, pharmaceuticals have been produced using a method known as “batch manufacturing,” a multi-step, lengthy process that usually involves the use of large-scale equipment. However, recent advances in manufacturing technology have prompted the pharmaceutical industry to consider moving away from batch manufacturing to a faster, more efficient process known as “continuous manufacturing”. The Regulatory Agencies are taking proactive steps to facilitate the pharma industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and to address many of the underlying causes of drug shortages and recalls. Our speaker will provide his expert practical experience of continuous manufacturing.

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


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.