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

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

Draft Guideline on the acceptability of names for human medicinal products


The scope of this guideline is to provide information on the overall procedure for submitting and reviewing the acceptability of proposed (invented) names for human medicinal products processed through the centralised procedure, as well as detailed guidance on the Read more

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


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 Read more

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

, , , , , ,

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.


Season’s Greetings

, ,
Season's greetings

Horizon Europe Association – Statement on behalf of the European Health Stakeholder Group

, , ,

As representatives of the European Union’s health community, we are united in our call for the United Kingdom’s association to Horizon Europe to be formalised as soon as possible.

Horizon Europe aims to tackle the major global challenges of our time but achieving this aim will be impossible without international collaboration. The COVID-19 pandemic has clearly highlighted the critical value of global partnerships to advance scientific discovery and innovation, especially where speed is of the utmost importance. The depth and strength of successful international collaborations resulting from the relationships built up over many years with the UK is long established.

We have all reaped the mutual health benefits of these collaborations. Together, we have significantly advanced health care across Europe, saving and improving citizens’ lives. Clinical trials, particularly on diseases with limited patient populations, have been heavily reliant on EU-UK collaboration, while close research and innovation partnerships continue to accelerate life-changing medical research.

Going forward, we must continue to work together in order to meet the challenges of our swiftly changing world. Our ability to respond to the threat of climate change and outbreaks of new diseases like COVID-19 has been greatly improved by close scientific and clinical partnerships across Europe. Knowledge and discovery do not stop at borders: the shared global challenges we face require joint solutions. Collaboration through the research framework programmes is a springboard to productive partnerships across the world.

As a community, we welcomed the provision in Protocol I of the EU-UK Trade and Cooperation Agreement for the UK to associate to Horizon Europe. The subsequent Q&A document from the European Commission provided us with confirmation that we could apply with UK entities for the first multi-beneficiary calls. Based on these reassurances, EU health research organisations have been working with UK partners on the understanding that they would shortly become full associate members. However, the absence of a clear timeframe for formalising UK association is now causing increasing concern. We notice too with regret that while the specialised committees for other policy areas are already established, the Specialised Committee on Participation in Union Programmes has not yet even had its first meeting.

This continuing uncertainty risks jeopardising current and future research partnerships, and time is fast running out. With the first Horizon Europe grant agreements nearing finalisation and new calls expected imminently, UK association must be formalised. Now is the time to act. Further delays or the spectre of non-association would result in a missed opportunity to tackle the major challenges of our time, diminish our collective research capabilities and weaken Europe’s position in the highly competitive global market.

Many profound and long-lasting EU-UK research partnerships are at stake. These are of high value to Europe as a whole – and to the world at large. We owe it to future generations in the EU and beyond to ensure that the new EU-UK relationship best serves them through research.

We stand with our colleagues in the European Union’s research and innovation community in urging the European Commission to formalise the United Kingdom’s association to Horizon Europe without further delay.

The European Health Stakeholder Group

The joint statement in full can be found in the following versions: EN, FR and IT.


Consultation on the reform of the European pharmaceutical legislation

, ,

In November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe. The Pharmaceutical Strategy identifies flagship initiatives and other actions to ensure the delivery of tangible results: https://ec.europa.eu/health/sites/default/files/human-use/docs/pharma-strategy_report_en.pdf As part of the implementation of the strategy, the Commission is evaluating the general pharmaceutical legislation and assessing the impacts of possible changes in the legislation as described in the relevant inception impact assessment.

This consultation aims to collect views of stakeholders in order to support the evaluation of the existing general pharmaceutical legislation and the impact assessment of its revision. A summary on the outcome of the public consultation will be published by the Commission services on the ‘Have your say’ portal. The Commission’s questionnaire is under consideration by our Bureau members and the link is as follows: https://forms.office.com/r/EUHkxBN3Sk. The deadline to participate in this consultation call is the 10th December. 

We thank you for your participation.


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

, , , , , ,

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

, , , , , , ,

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

, , ,

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.