The Vice-President for Technical and Professional Development, Piero Iamartino (Italy), reported on the EMA meeting for interested parties, in particular the large number of pending GMP-related issues. The Executive Director, Jane Nicholson, reported that submissions had been made by EIPG on the EMA Concept Paper for the revision of Chapter 7 of the GMP Guide and Part III proposals for the Site Master Files. The outcome of two meetings held with the Head of Unit 4 and staff at the Directorate General for the Internal Market and Services, where the issues relating to the Bologna declaration and the place of the Bachelor of Pharmacy were raised by the Commission and a presentation on the need for Masters level education for all pharmacists was made on behalf of EIPG by our Belgium Association, VAPI/UPIP, was also reported.
In one of the working parties, the Vice-President for Communications, Claude Farrugia (Malta) led a discussion on the latest proposals for amendments to Directive 2001/83/EC to prevent entry of counterfeit medicines into the supply chain, following his participation at the EPSA Annual Congree in Krakow together with speakers from EFPIA, GIRP and the PGEU. He commented that the latest proposals appear to be an attempt to juggle the need to raise standards whilst trying to mitigate the cost of implementing these standards, and cautioned that half measures will be worse than no measures because they will give a false sense of security. The group concluded that the proposed legislation and its implementation represented a major challenge that had to be undertaken to protect public health. Proposals for the future of the clinical trial supply chain were also presented by Philippe van der Hofstadt (Belgium). In the second working party, the PHARMINE project coordinator, Professor Bart Rombaut, from Brije University, acted as rapporteur for a review of industrial pharmacy competencies and the need for Advanced Masters and Diploma courses.
Presentations were also made from the Italian delegates present in appreciable numbers at the General Assembly, including a report by Dr Giorgio Bruno, Qualified Person for Corden Pharma, on the professional development of the Qualified Person in the Italian pharmaceutical industry.
The update of the year’s activities showed EIPG to have been active in a number of key fields. A report by John Jolley (Great Britain) of the EMEA meeting with “interested parties” demonstrated a large number of pending GMP related issues. Although legislation including Annex 16 is still to be updated and the QP discretionary powers remain under discussion in Brussels, it was agreed that the updated EIPG Code of Practice for Qualified Persons should be issued with a proviso that it will be further amended in line with new regulations. A discussion of the threat from counterfeit medicines and strengthening the medicines supply chain was led by Claude Farrugia (Malta). Further representation to the European Commission concerning the responsible pharmacist and draft EIPG Guidelines on Good Distribution Practice of Medicinal Products were agreed by a working group on the topic. A second working group considered a draft document on Continuing Professional Development for Regulatory Affairs prepared by regulatory staff in Germany, Britain and chaired by Valérie Lacamoire (France). The President of EAFP, Jeffrey Atkinson led a discussion on the subject matter of the third working party, which dealt with the PHARMINE project, culminating in an agreement for Greece to lead a a brain-storming session of the employment opportunities available for pharmacists in the future pharmaceutical industry at the next General Assembly.
Several other initiatives were also reviewed at the meeting, including a Belgian document submitted to their Agency on the Guidance on GMP requirements in Phase 1 and exploratory clinical trials. Previously, it had been agreed that this should be “Europeanised” and a group of delegations will provide further input to Philippe Van der Hofstadt (Belgium). Harold Smeenge (Netherlands) also agreed to take the lead in developing contacts with the European Pharmacy Students Association (EPSA) that had been initiated by Denmark over the past 12 months. It was noted that a representative of EIPG from Belgium was attending the EPSA Annual Congress held in Reims.
The General Assembly concluded on the 20th April, with an invitation from Piero Iamartino (Italy) on behalf of the Associazione Farmaceutici dell’Industria (AFI) to hold the 2010 General Assembly in Italy; this was carried with acclamation.
The update of the year’s activities showed EIPG to have had an active year since the last General Assembly in Prague, particularly in establishing the EIPG as an active partner in consultations with the European Medicines Agency, thanks to the efforts of Piero Iamartino and John Jolley. EIPG had also been active in matters concerning education. An invitation to the Conference of the European Association of Faculties of Pharmacy (EAFP) had resulted in a joint submission between EIPG, EAHP, PGEU and EAFP for European Commission funding for two projects: PHARMINE – a review of undergraduate pharmacy courses – and PHARMIND – a survey of the competencies needed for a career as an industrial pharmacist. The new Executive Director, Jane Nicholson, also attended a meeting of the EAHP, at which an update of the European Medicines Research Academy was reviewed, and held discussions with the Executive Board of the Hospital Group on matters of mutual interest.
A number of key presentations were made in the course of the General Assembly, foremost among them an update on the EIPG Guide to Good Regulatory Practice, by Valérie Lacamoire (France), who was assisted by regulatory affairs pharmacists from Germany and Great Britain. In the light of these recommendations, regulatory affairs pharmacists from Italy, Belgium and Denmark subsequently expressed interest in setting up a the working group on Continuing Professional Development for pharmacists in regulatory affairs. John Jolley (Great Britain) delivered a talk entitled “Industry Implications of Pharmaceutical Quality ICH Guidelines”, outlining the implications of ICH Q8, Q9 and Q10 guidelines in pharmaceutical product life cycles, whilst the deliberations of the assembly on the education of industrial pharmacists were supported by a presentation from the invited speaker Prof. Alfred Vella, Pro-Rector of the University of Malta, on “The Bologna process and university reform”.
National initiatives in the Member States were also communicated to the Assembly. Jean Pierre Pacconi (France) delivered two presentations, the first representing an update on the competency scheme for the education of industrial pharmacists in France, and the second an initiative in the form of a new working group in France for recommendations in achieving a reliable network for cool transport. The latter elicited considerable interest amongst the delegates and will constitute one of the topics of discussion at the next General Assembly. There was also a presentation by Philippe Van der Hofstadt (Belgium) on a Belgian initiative for cGMP in clinical trials, well received by Italy, Netherlands and Great Britain.
The Working Group on undergraduate and postgraduate education, attended by delegates from Great Britain, Czech Republic, Netherlands, Finland, Sweden, France, Hungary and Spain discussed the competencies and skills required to become an Industrial Pharmacist in different EU countries, with the two main strategies being a specialised cycle for industrial pharmacists as seen in France and Finland, or a general degree with orientation in later years, as seen in Netherlands, Spain and Czech Republic. France and Netherlands are currently working on competencies for industrial pharmacists, and the next assembly will discuss their feedback in considering initiatives in CPD for industrial pharmacists. The second Working Group, discussing future employment prospects of industrial pharmacists, was attended by delegates from Germany, Belgium, France, Portugal, Hungary, Latvia and Great Britain. The group conducted a SWOT analysis of future employment prospects of industrial pharmacists in Europe in the light of increasing globalisation trends and downsizing of companies, coupled with decreasing numbers of NCE’s and increased generic new drug approvals. A third working party, attended by Malta, Italy, France, Netherlands and Greece, discussed an EIPG position paper on counterfeit medicinal products in response to the public consultation paper issued by the European Commission. This position paper was concluded following the General Assembly and submitted both to the European Commission and the MHRA.
The General Assembly concluded on the 20th April with the election of Jakob Bjerg Larsen (Denmark) and Claude Farrugia (Malta) to the Vice-Presidency of EIPG. In the process of the President’s concluding speech, the Assembly concurred that EIPG should, throughout the coming year, focus its efforts on technical directives and guidelines, communications, and maintenance of professional standards. The Assembly also approved Latvia as the venue for the General Assembly of 2009.
The Working Group on Qualified Person matters, chaired by Italy, discussed a review of Annex 16 to the EU Guide to Good Manufacturing Practice in the light of last year’s EMEA Reflection Paper on QP discretion. The Italian and Irish delegations will produce a draft update to Annex 16 for discussion. The Working Group also voiced its concerns over counterfeit product penetration in wholesale dealing activities in the European Union. It was agreed that EIPG should write to the European Commission recommending that all wholesale dealers should employ a pharmacist as the “Responsible Person”; such an explicit requirement does not exist in some Member States. The French delegation also indicated that product traceability measures implemented in France included a recent decree making it compulsory for all packs of medicinal products to be printed with a data matrix bar code based on EAN 13 by 2010; this bar code will include not only the reimbursement number but also the batch number and expiry date.
The Working Group on Undergraduate Education, chaired by Sweden, continued its discussions on the identification of undergraduate pharmacy programs in Europe best suited to the development of industrial pharmacist. The Danish undergraduate program was identified as one of the most suitable, since approximately 60% of pharmacy graduates find employment in the pharmaceutical industry. Consequently, it was agreed that the Swedish and Danish delegations will continue to develop the activities of this working group in conjunction with the European Association of Faculties of Pharmacy (EAFP).
The elections held in the course of the General Assembly saw the United Kingdom re-elected to the Presidency of EIPG, whilst France was elected to the Treasury. The Group also approved the membership of the newly formed Industrial Pharmacists Section of the Pharmaceutical Society of Latvia, and welcomed the interest from Bulgaria and Hungary in possible future membership.
Two interesting presentations were delivered during the Assembly. Dr Miroslav Janousek, Corporate Regulatory Affairs and Quality Director of Zentiva, the leading generic pharmaceutical manufacturing company in the Czech Republic, gave a review of the development of the pharmaceutical industry in Central and Eastern Europe. Dr Janousek described how the development of competence with quality as a driving factor has led to increased employment of industrial pharmacists within his company. The second presentation was a comprehensive review by Professor Miloslava Rabiskova on the academic research being undertaken in the two schools of pharmacy in the Czech Republic. Professor Rabiskova’s group in Brno concentrates on research in the field of pellets and coating systems.
The Working Group on Continuing Professional Development (CPD) discussed a draft guidance document for Qualified Persons, Technical Directors and other Responsible Persons. The aim is to publish these guidelines to assist the needs of co…ntinuing professional development for industrial pharmacists in Europe. The Society’s CPD process was reviewed, including the CPD portal on the Society’s web page. Feedback from other delegations was that the impressive work of our Society should be followed and similar systems of assessing CPD should be adopted in other European countries.
The Undergraduate Education Working Group focussed on how EIPG could influence the teaching of Industrial Pharmacy in the curriculum of undergraduate courses. Patricia Munoz, a member of the PGEU staff who has been closely involved with the legislative process of the Directive on Recognition of Professional Qualifications and who follows the topic of mobility and recognition of pharmacists, attended the meeting as an observer. One recommendation agreed by the General Assembly was the setting up of a network of European universities & industrial pharmacists associations to benchmark a curriculum for the future industrial pharmacist under the auspices of a Commission research project.
Other recommendations were to influence the pharmaceutical industry to encourage industrial pharmacists to act as guest lecturers at schools of pharmacy; to highlight the importance of industrial lectureships and chairs in industrial pharmacy; to upgrade the EIPG website to include a page on careers in the pharmaceutical industry. The advertising of careers materials will be discussed with the European Pharmaceutical Students Association.
The meeting was addressed by Professors Macheras and Rekkas from the School of Pharmacy, University of Athens. They described proposals for the revisions of the undergraduate course, the status of the Bologna process in Greece and their participation in the meetings of the European Association of Faculties of Pharmacy (EAFP).
The President of the European Hospital Pharmacist Group, Jacqueline Surugue, who attended the meeting as an observer, described moves to harmonise the labelling of drug concentrations for liquids including injections. One recommendation her Group has made to the EMEA is to move away from expressing any concentration as a percentage on all labels of medicinal products because this has caused confusion and administration errors amongst the nursing profession.
The status of mutual recognition agreements was discussed. The expectation of the FDA joining the Pharmaceutical Inspection Convention Forum was welcomed as it will allow verification of standard operating procedures and may reduce the number of FDA inspections of European pharmaceutical sites in the future.
A survey issued by a workshop in April 2006 across a broad spectrum of stakeholders (medical doctors, pharmacists, patients & industry) has shown inconsistencies in the reporting of Adverse Events. It was suggested that the reporting of Adverse Events was being hampered by the fear of litigation that faced reporters of such events. It was agreed the position would be improved if other countries followed the example of the Danish government which has passed a law giving immunity from such litigation to the reporters of Adverse Events.
The Italian and Irish delegations were elected as Vice-Presidents of EIPG. At the end of Day 1, there was a presentation by Manolis Mitakis on the history of Pharmakon and pharmacy in ancient Greece.
The working group on Undergraduate Education and Training was updated on the Italian education system by Prof Carla Caramella from the University of Pavia. A list of subjects considered missing from the undergraduate course as described in the last Advisory Committee meeting report will be discussed with the European Community and Hospital pharmacists Groups. The meeting noted that the majority of countries in the EU appear to be adopting the Bologna declaration and working with the model of 300 credits over 5 years. It was agreed that there is a need to evaluate the competencies of the workforce in the pharmaceutical industry of 2010 and that the minimum competencies both in terms of subject knowledge and teaching methods should be reassessed in conjunction with the other branches of pharmacy and the European colleges of pharmacy.
The working group on Continuing Professional Development and the Qualified Person (QP) discussed a survey undertaken amongst the membership by the Italian delegation. Key points discussed were the Annex 16 requirements, points 8.3 and 8.4 on minimum requirements and the professional obligation to broaden ones knowledge when moving from one to another area of manufacture. It was agreed that minimum requirements should be satisfied by continuing education and responsibilities lay with the QP, the providers of continuing education (CE) and with the competent authorities who should assess, audit and certify CE providers and QP compliance. It was agreed that the working group should put together proposals on the methods of implementation.
During the meeting, Silvia Fabiani from the Italian Regulatory Agency discussed the work of the Committee for Human Medicinal Products and the future challenges for the European Medicines Evaluation Agency. The results of a usage survey of the EIPG website were reported by the Swedish delegate and a list of policy rules for the website is to be agreed.
The 2005/6 Strategic Plan for EIPG was agreed and the Danish delegation was elected as vice president for the next 3 year period.