The President opened the General Assembly by welcoming the delegates and guests, and thanking the Scottish Office of the Royal Pharmaceutical Society for their work in organising the Assembly and the symposium, as well as members of the Bureau and the Executive for their hard work throughout the year. He reiterated his vision for EIPG to enhance the profession for the Industrial Pharmacists of the future, to uphold Quality and Safety Standards, to be an ambassador for European Industrial Pharmacists and to be in partnership with hospital, community and academic pharmacists. In particular, Jean-Pierre Paccioni said that EIPG is to help industrial pharmacists to develop the capacity to say YES and the duty to say NO, whilst always remembering that behind each carton of medicine, there is a patient. Messages from the European Association of Hospital Pharmacists and the European Pharmaceutical Students Association wishing EIPG success at the General Assembly were also communicated.
After the presentation of national hot topics by the delegates of the members present, Patricia Munoz, representing PGEU, gave an update on the current activities of the organisation. She was followed by Andrew Powrie-Smith, representing EFPIA, who gave a presentation on the EFPIA Disclosure Code, and Tracy Lovatt from the MHRA, who gave an update on the progress being registered on the new GMP Annex 16. In the working groups, the working group on the new tasks and responsibilities of the Qualified Persons arising from the revised Annex 16 discussed the impact of the new version of this Annex on the professional duties of the industrial pharmacist, whilst the working group on Shortages of Medicines reviewed the current status of medicines shortages throughout Europe and formulated an action plan for EIPG, highlighting the need to re-engage the European Commission in discussion, join other stakeholders addressing the problem, and work towards a pan-European integrated shortage information system.
The second day of the General Assembly commenced with the presentation of the finance and strategic plan. The elections to the Bureau followed thereafter: Maurizio Battistini (Switzerland) was elected to the post of Vice-President European Affairs while Piero Iamartino (Italy) was elected as Vice-President Technical and Professional Development. Presentations on the activities of the Special Interest Groups (SIGs) were made by Amon Wafelman and Georgina Gal, chairs of the Production SIG and Regulatory Affairs SIG, respectively, followed by the Communications Annual Report by Vice-President Communications Claude Farrugia. The Assembly confirmed Paris as the venue for the General Assembly of 2016, and concluded by thanking Janet Halliday and the Royal Pharmaceutical Society for their efforts in hosting a successful meeting.
The President opened the General Assembly by welcoming the delegates and guests, and thanking the BIPA delegation for their work in organising the Assembly and the symposium, as well as members of the Bureau and the Executive for their hard work throughout the year. He declared that the role of EIPG is to enhance the profession for the industrial pharmacists of the future, to uphold quality and safety standards, to be an ambassador for European industrial pharmacists and to be in partnership with hospital, community and academic pharmacists. The President stated that his aim was to be more proactive with European Authorities, and to improve contact with EFPIA on topics such as drug shortages and serialisation.
After the presentation of national hot topics by the delegates of the members present, Amon Wafelman, NIA delegate, gave an update on the Special Interest Groups (SIGs), which could fit within the EIPG structure and add value to the organisation and its members by using the intellectual potential of delegates working on subjects within their field of expertise throughout the year, with the resulting cooperation between delegates strengthening mutual contact and bonding. Jamie Wilkinson, Pharmaceuticals and Professional Affairs Advisor within the PGEU, gave an update on the activities and objectives of the PGEU, following which Jacques Morénas provided a general overview of the direction and philosophy of future legislation concerning ICH Q8, 9, and 10.
In the working groups, the working group on European GMP discussed the upcoming changes in key chapters of EU GMP Part I, along with the proposal for a new guideline on “shared facilities” and the revised version of Annex 16, whilst the working group on competencies for biotechnology discussed the training and professional competences required by pharmacists in view of the increasing role of biotechnology in the development of new pharmaceuticals and therapies. The day was brought to a close by presentations from EAHP President Roberto Frontini and EPSA President Tiia Metiäinen.
The second day of the General Assembly commenced with a joint presentation of the Bureau’s activities during the past year by the President and by Executive Director Jane Nicholson, highlighting representations made by EIPG during the year, recent successes with educational matters and submissions to the European Commission and the European Medicines Agency. Additional presentations were made on the finances by Treasurer Valérie Lacamoire, and the Internet Annual Report by Vice-President Communications Claude Farrugia. A number of elections dominated the Agenda of the day. The Irish association PIER (Pharmacists in Industry, Education and Regulatory) was approved as a Full Member, while the Moroccan association COPFR (Conseil de l’Ordre des Pharmaciens Fabricants et Répartiteurs) was approved as an Observor to EIPG; on the other hand in view of the information that Irish association TIPPSA (Technical Industrial Pharmacists and Pharmaceutical Scientist Association) had disbanded, the Association was removed as a Full Member of EIPG. Claude Farrugia (Malta) was elected to the post of Vice-President Communications while Anni Svala (Finland) was elected as Vice-President Education and Training. The new Internal Rules were approved by the Assembly, which also confirmed Edinburgh as the venue for the General Assembly of 2015.
Following a summary of the Bureau activities for the past year by EIPG President, Gino Martini, and EIPG Executive Director, Jane Nicholson, EIPG Vice-President Claude Farrugia reported on the progress on the EIPG and european Industrial Pharmacy Websites. The various Social Media sites were discussed and it was agreed those of Facebook and Twitter are significant and appropriate for a younger audience whereas LinkedIn is for older business people. A number of other presentations were made in the course of the General Assembly. Patricia Munoz, a guest from the Pharmaceutical Group of the European Union (PGEU), gave an update on recent events regarding the Free Movement Directive. Bart Rombaut, President of the European Association of Faculties of Pharmacy (EAFP), presented the PHARMINE consortium report, and gave updates on PHARM-QA, and the new proposal for competencies needed for the teaching of biotechnology, PHAR-IN. Par Tellner, a guest from the European Federation of Pharmaceutical Industries and Associations (EFPIA), gave an update on events at EFPIA, in particular the progress on the Innovative Medicines Initiative (IMI).
In the working groups, the first group discussed the Falsified Medicines Directive. The Working Group reconfirmed the EIPG Position Papers on Good Manufacturing Practices and inspections of API manufacturers, and expressed concerns on the imminent implementation of API certification measures, and the state of uncertainty regarding the unique identifier. The second group discussed medicines shortages. Many member states reported a state of medicinal product shortages in their countries, and identified parallel exportation as a contributing factor. The potential on the API Certification measures under the Falsified Medicines Directive to exacerbate the problem was also noted. It was felt that in order to address the issue there should be better collaboration between health authorities and all the players in the pharmaceutical supply chain, and that supply chain players should review their missions of supplying medicines to the patient and undertake risk assessments of critical products. An improved monitoring systems, coordinated by the European Medicines Agency, was also called for.
The evening of the first day of the Assembly was notable for a ceremony in which outgoing President Gino Martini was thanked by the delegates at the General Assembly for his years of service as President. EIPG Treasurer Jean-Pierre Paccioni, EIPG Exeutive Director Jane Nicholson, and EIPG Vice-Presidents Piero Iamartino and Claude Farrugia gave tribute to Gino Martini’s achievements, and presented a gift to commemorate the occastion
The second day of the General Assembly commenced with the election of Jean-Pierre Paccioni (France) as President, and Valérie Lacamoire (France) as Treasurer, and also agreed that outgoing President Gino Martini would take the position of Past President. The new President outlined his strategy for the coming three years, calling for closer collaboration with key pharmaceutical stakeholders, the establishment of a new EIPG Finance Commission, working groups on technical issues, and widened visibility for EIPG. The Assembly also approved Sofia as the venue for the General Assembly of 2014.
Following the outlining of the strategic proposals for the upcoming year by the EIPG President, Gino Martini, the Executive Director, Jane Nicholson, reported progress over the past year with discussions on the update to the Professional Qualifications Directive and contact with sister associations and with various members of the EPSA executive. Submissions had been made by EIPG to the European Commission or the European Medicines Agency on several of their concept papers and on updates to Good Distribution Practice and Annex 16 of Good Manufacturing Practice. EIPG Vice-President Claude Farrugia and european Industrial Pharmacist editor-in-chief Joe Ridge reported favourably on the website and journal, respectively.
A number of other presentations were made in the course of the General Assembly. Bart Rombaut, President of the European Association of Faculties of Pharmacy (EAFP), presented the foundation level framework for the Common Competence curriculum and the advanced level frameworks specific to hospital and industrial pharmacy. He explained the ongoing project of pharmacy education in Eastern Europe and the proposed pharmacy education Quality Assurance system. Heitor Costa, APIPHARMA Executive Director, made a keynote speech on the pharmaceutical industry in Portugal.
In the working groups, the first group discussed measures to elicit greater membership feedback for future EIPG position papers, in order to continue to ensure that EIPG positions submitted are representative of the opinions of all member organizations. These included that an EIPG rapporteur on a consultation document should carry preparative work on the document and prepare a draft position paper that would then be distributed, with member states indicating their agreement or making recommendations for changes. The rapporteur would thus indicate the more important aspects of the paper that would allow member states to focus their attention on key issues. The group also agreed that EIPG should engage in measures that would directly seek feedback from the membership of the national associations. In the second group, Jane Nicholson initiated the discussion on the Free Movement Directive by referring to the EIPG response from March 2011 to the Commission’s consultation. Further interventions were made by the representatives of invited associations, including Patricia Munoz (PGEU), Roberto Frontini (EAHP) and Bart Rombeau (EAFP).
The second day of the General Assembly commenced with an Extraordinary General Assembly that approved a significant revision to the EIPG Statutes, widening EIPG membership to include members of the European Economic Area and European countries having in place a mutual recognition agreement with the European Union on the compliance and control of regulated medicines, extending the Bureau to include a President, four vice-Presidents and a Treasurer, and officially creating the post of Executive Director. The Assembly continued with the election of Gunther Pauwels (Belgium) as Vice-President European Affairs, Piero Iamartino (Italy) as Vice-President Technical and Professional Development and Nuno Moreira (Portgual) as Vice-President Education and Careers. The Assembly also elected Norway to full membership within the Group and approved Brussels as the venue for the General Assembly of 2013.
As outlined by Gino Martini, the report on the year’s activities showed EIPG to have had a busy year since the last General Assembly, particularly in its role as an active partner in consultations with the European Commission on educational matters and with the European Medicines Agency on technical guidelines. EIPG response to consultations on various chapters of the GMP Guide, the QP Declaration Template and the Professional Qualifications Directive were all submitted, whilst an update to the EIPG guidelines on Good Distribution Practices was in the final stages of preparation, and a working group led by the Ordem dos Farmaceuticos, Portugal, is drafting a Code of Practice for Pharmacovigilance. All of these documents were key to the activity seen on the EIPG’s website, as described by Claude Farrugia in his website report.
A number of other presentations were made in the course of the General Assembly. Michael Murray, representing the ABPI in London at the EFPIA working party meetings, presented a European Quality Regulation Update. He discussed the industry views on the recent consultations of proposed amendments to Chapters 5 and 7of GMP guidance, the concept paper on storage conditions during transport and the QP declaration for APIs. Also, he described the status, key issues and timelines for implementation of the Falsified Medicines Directive. A draft of the updated Statutes of EIPG was also considered by the General Assembly, initially brought about by the proposal to update the membership of the Bureau but now having been extensively modernised. One of the proposals which elicited most discussion was whether the Member Associations should be restricted to Member States of the European Union or have a wider definition to include the European Economic Area, Accession countries, European countries which have a Mutual Recognition Agreement with the European Union in relation to conformity assessment of regulated medicinal products or simply any country of “Europe”.
In the working groups, the results of the recent Membership Survey were debated, including ways of improving the systems of lobbying in Europe. A list of pharmacists who are expert in specialist areas of industry is to be compiled from Member Associations to assist with responding to scientific issues. These areas would include: Production/Quality Assurance; R and D; Commercial/Sales and Marketing; Regulatory Affairs; Biotechnology products / Medical Devices; Counterfeits; Clinical Trials management; Wholesale Distribution; and Pharmacy Education. An education working group reviewed the report of Pharmine 1 and considered a submission to the Education, Audiovisual and Culture Executive Agency (EACEA) for a pilot to review specific advanced level competencies and how best these should be delivered ( for example, part-time distance learning in conjunction with an HEA) for pharmacists working in industry. National reports from Member Associations also described various methods used to lower the prices of pharmaceuticals, in order to reduce health care budgets. Some members indicated the price reductions were considered so low that they were unsustainable. Site closures and headcount cuts, particularly in the biotechnology industry were reported. However, it was not all doom and gloom. Italy marked the 50th anniversary of the founding of AFI with a national symposium attended by over 1000 participants. During the year, AEFI has run 36 specialist courses in Spain attended by 1753 participants.
The General Assembly concluded with the election of Claude Farrugia (Malta) as Vice-President Communications of EIPG and the co-option of Par Tellner (Sweden) as Vice-President Education and Careers. The Assembly also approved Lisbon as the venue for the General Assembly of 2012 and Brussels as the venue for the General Assembly of 2013.