From the Bureau Archives - European Industrial Pharmacists Group (EIPG)

Steps forward towards the new framework for HTA


By Giuliana Miglierini The long-waited European regulation on Health Technology Assessment (HTA) was adopted by the Council of Europe on November 9, and it has now to pass through the final endorsement of the European Parliament as the last step Read more

Commission establishes portfolio of 10 most promising treatments for Covid-19


by Giuliana Miglierini The second phase in the development of new medicines to treat Covid-19 - a part of the EU Strategy on Covid-19 Therapeutics launched in May 2021 - has reached a cornerstone with the announcement made by the Read more

A new role for EMA and a pilot project for the repurposing of medicines


by Giuliana Miglierini A draft agreement was reached at the end of October between the Council of the European Union and the European Parliament to reinforce the mandate of the European Medicines Agency (EMA) with reference to crisis preparedness and Read more

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.


Virtual Symposium: The Post-COVID Era and Pharmacy

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As we all know the world has been ravaged by the COVID-19 pandemic which has affected many lives and unfortunately cost many lives. Although dreadful and harrowing, the pandemic has revealed an unprecedented level of collaborations between Scientists, Industry and Regulators. We have witnessed enormous advances in medicines and vaccines development, clinical trials design and regulatory flexibility. which has helped to put new vaccines on the market in less than 13 months, a number of repurposed medicines to treat COVID-19 and the implementation of one the largest vaccination programmes the world has ever witnessed en masse.

As a result of these outcomes, EIPG believes that the lessons learned from COVID-19 should define our future as Pharmacists in that we should leverage best practice. As a result we have developed an informative symposium to discuss these lessons and what the future will hold and more importantly how pharmacists can shape the future in a post-COVID Era.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information or confirm your participation through this form.


The importance of Knowledge Management in both the Development and Manufacture of Medicinal Products (Webinar)

In EIPG’s and PIER’s next webinar, Marco Adami and Alessandro Regola will share their practical experience of problems and opportunities in knowledge management encountered during their careers in the pharmaceutical industry.

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


The Practical Implementation of EU Regulations for Medical Devices and in vitro Diagnostic Medical Devices (Webinar)

In EIPG’s and PIER’s next webinar, John Deavin will review current Medical Device Directives and the timetable for transition to the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), the proposed UK system.

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


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

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. Comments are mainly focused on the key issues about the aseptic process, such as premises, personnel, production technologies and process monitoring.

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


How a pandemic has affected the pharma industry (Webinar)

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 how to achieve robust research “at a pace” especially when vaccines for the elderly do not usually produce extensive immune response. She will explain the positive aspects of the management of clinical trials during COVID and whether there are likely to be permanent changes resulting from the experience with COVID. She will reflect on what we have learnt about the sudden switching to manufacture of medicinal products needed in Intensive Care Units and other supportive medicines for COVID patients. She will consider whether the established management systems set up to prevent shortages of medicines are working post-COVID or whether COVID-related medicines are causing shortages of other medicinal products.

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


EIPG publishes updated version of Code of Practice for Qualified Persons

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 requirement, taking into account the practical experience of many European industrial pharmacists in their role of QPs.

Authored by EIPG Vice-President Technical and Professional Development Piero Iamartino and EIPG Vice-President European Affairs Maurizio Battistini, with contributions by Luciano Gambini (Italy), and contributions from Italy, Belgium, Spain, UK and Czech Republic, the scope of this document to provide a living Code of Practice by ensuring a constant updating as a consequence of the introduction of new European requirements pertaining to the QP and considering the possible integration of new comments based on the contributions of EIPG members.

The EIPG Code of Practice for Qualified Persons 2020 is available on the EIPG Website in the EIPG Guides and Codes section.


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

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, provides guidance for the interpretation of the principles and guidelines of GMP for both human and veterinary medicinal products. The document intends to bring clarity to areas which have been unclear for some time, and the speaker will discuss the background to the Annex, the challenges which have existed within the EU Regulatory Framework, and how the proposed Annex may or may not address these challenges. The speaker will suggest potential areas of concern, and how delegates may wish to communicate these to the European Commission both via the European Commission’s own communication process, and through the participation of their member organisations in the consultation process within the European Industrial Pharmacists Group.

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


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

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 ago scientists began to genetically pick apart the molecular make-up of these rhythms, and discovered that each of our cells has the capacity to tell the time of day. This has opened up a new field in biology, called chronobiology, which is the study of our body clocks in health and disease. Today, this field has begun to unpick the implications of our body clocks in terms of drug development, efficacy and toxicity. This has major implications as up to half of the 100 top selling medicines are against a target that is controlled by our molecular clock, leading to daily changes in the expression of this target. Chronotherapy has the aim of harnessing our body clocks and these subsequent rhythms to improve the efficacy and safety of drugs.

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