EANM General Meeting on Education in Radiopharmacy
Minutes of the meeting Saturday 22 November 2003
EANM Secretariat, Hollandstrasse, Vienna , Austria
Present: See added list of participants.
- Welcome to all. It shows the importance of education and regulation that so many have come.
The certification program for education in radiopharmacy and radiopharmaaceutical
Several courses on Radiopharmaceutical Chemistry and Radiopharmacy, covering the Curriculum accepted by the European community of radiopharmaceutical chemists and radiopharmacists as represented by the Committee on Radiopharmacy of the EANM were successfully organised during the last years in Frankfurt and Ljubljana (Block 1, Radiopharmacy), Saclay and ZÃ¼rich (Block 2, Radiopharmaceutical chemistry), Leipzig and Saclay (Block 3, Related Subjects).
It was considered diligent to lay the future of this education in the hands of the Board on Education.
Steps have been undertaken to create a faculty of Radiopharmaceutical Chemistry and Radiopharmacy in the School of Nuclear Medicine; at the December Meeting of the Committee on Education it is hoped to bring this process a step further. The Board on Education in Radiopharmacy will constitute the faculty of this part of the school. The board will consist of one representative of each of the courses complemented by three independent members and (if that is agreeable with the members of the Medical Faculty in the School) one physician appointed by the Medical Faculty in exchange for a member of our Faculty who should join the board of the Medical Faculty. For the present time the existing board will serve, with the provision that Alphons Verbruggen (Leuven, Belgium) will replace Willem Vaalburg (Groningen, The Netherlands). Depending on the outcome of the meeting of the Committee on Education in December, the board will be newly constituted along the rules outlined above at the next board meeting 8. May 2004. Distance learning should have a place in future considerations also.
To evaluate the application of Students for certification the student has to approach the Chairman of the board, who will deal her / him a board member who will do the actual evaluation. For the theoretical part the criterion will be the passing of the final exams of the three blocks. Students with notorious previous knowledge possibly exceeding the course contents may be allowed to attend only part of the courses, but to get the certificate the exam('s) have to be done and passed.
Diploma's (the certificate is postgraduate, the students must have a university diploma at least at the masters level) have to be checked (national delegates will be appointed who may be able to help to judge the diploma's).
For the practical part the required time of experience is changed to two years. To judge if the practical experience gained in that time covers the syllabus, a check list will be provided where the points will have to be signed off by the supervisor. The board member collecting the material of a student should use his judgement about the adequacy of the institutions where the experience was gained. Where large deficits are apparent, the board member must advise and help the student to gather some experience at another institution.
The ETH Postgraduate Diploma courses have been held every two years, the INSTN courses every year. It was agreed that in the future there should be one series of courses every year, INSTN + Ljubljana alternating with ETH. French regulations have to be changed to make this possible.
Next courses: INSTN Block 2 resp. 3, November 2003 resp. March 2004. Ljubljana Block 1, September 2004. ETH, Block 3 (Leipzig), March 2004.
Fees of at least 1000 Euro will be charged to the students. Students who can not afford the cost of attending, may go after bursaries of the IAEA, the EANM Marie Curie Fund (see www.eanm.org) or the student help provided by the International Society of Radiopharmaceutical Chemistry and Biology. The suggestions for help will appear on the website of the EANM.
In the nuclear medicine laboratories (radiopharmacies) of the nuclear medicine
clinics in the hospitals in European countries quality assurance varies from non
existent to good manufacturing practice level. Thus at the business meeting of the
Committee on Radiopharmacy of the EANM in Vienna 2002 it was deemed of urgent
interest to provide the Nuclear Medicine community in Europe with guidelines,
which would assure a necessary and sufficient level of safety and efficacy in
the production, reconstitution and handling of radiopharmaceuticals in the
hospital, both for classical radiopharmaceuticals and PET products. It was
anticipated to formulate draft guidelines for the classical nuclear medicine
radiopharmacy and special good manufacturing practice rules for the PET
After discussions within the radiopharmacy and radiopharmaceutical chemistry community, amongst others at the annual meeting of the Radiopharmacy Group of the German Society of Nuclear Medicine (DGN), the Committee has adopted the strategy of starting to develop "Draft Guidelines for Radiopharmacy" for the Nuclear Medicine laboratories and to adapt the "Preliminary draft regulations on current good manufacturing practices for PET drugs" of the U.S. Food and Drug Administration for European purposes.
A first version of these documents was discussed at the business meeting of the Committee at the 11th European Symposium on Radiopharmacy and Radiopharmaceuticals in Innsbruck, 15-18 March 2003 and also in plenary session during the conference, where it was favourably commented upon by delegates from 32 countries (not all of them European).
Further consultations were with the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA) and the radiopharmacy expert circle of the Pharmaceutical Inspection Convention Scheme.
The Draft Guidelines on Good Radiopharmacy practices for Radiopharmaceuticals (GRPhP) in Nuclear Medicine and the Draft Guidelines on Good Manufacturing Practices for Positron Emission Tomography (PET) Radiopharmaceuticals have appeared in the EJNM, August 2003 and in the Radiopharmacy part of the EANM website.
Guidelines for classical nuclear medicine laboratories (written by Renata
- Something should be put in about: Officinal Preparation for use in the Hospital
- dispensing from a central radiopharmacy should be mentioned
- Cell labelling should get more attention
Guidelines for PET laboratories (adapted from the FDA draft regulationby Gerrit
- Commercial production of FDG can not be expected to be allowed under less than full GMP rules. The present rules are intended for small scale production (maybe including distribution to some neighbouring hospital who join the responsibility for production)
- Other more complicated preparation of radiopharmaceuticals (e.g.with radiohalogens, Iodine-123) should be included here.
- French Guidelines will appear soon
- Before submitting documents officially try to join forces with the authorities.
Strategy: After taking into account the remarks put forward about the drafts
(also those received by firstname.lastname@example.org
by E-Mail; E-Mails will be welcome until 24. December 2003) the Guidelines will be
presented to the appropriate body of EMEA.
Another approach will be to write a document (like the Guidelines) on the practice of radiopharmacy and radiopharmaceutical production for the European Pharmacopoea. If accepted this would give these documents the force of law. The idea will be put forward to the Pharmacopoea Commission by Alfons Verbruggen.
Verbruggen and Westera are authorised to proceed with both approaches, to coordinate and eventually to abandon the less successful strategy.
- Guidance to the Guidelines: will be necessary at some point but now seems to early.
- As a further strategy governments of the European countries will have to be convinced, that the appropriate education for people to run a radiopharmacy is the EANM certified postgraduate education. And that we need common guidelines for radiopharmacy practice. To achieve that national delegates will be appointed and asked to approach their governments on these matters.
- The national delegates will be the persons present at this meeting. For those countries represented by more then one person the following were nominated: Italy, Duatti; Germany: Coenen; Austria: Decristoforo; Finland: Nagren; France: Guilloteau (not present, replaced by Scherrmann for this meeting). In those countries who have not yet appointed a delegate the Nuclear Medicine Societies will be asked to put forward candidates.
For the presence of all, the EANM was sincerely grateful.
the next delegates meeting will be during the Radiopharmacy Meeting in Gdansk, Poland, 9-12. September 2004.