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The Pharmaceutical Journal
Vol 268 No 7190 p397-401
23 March 2002

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Careers

Opportunities for Qualified Persons

QP status is difficult to achieve

Opportunities for Qualified Persons

From Mr D. R. Jolley, FRPharmS

I was interested to read the excellent article on becoming a Qualified Person written by Peter Davies and Roy Daisley (PJ, 9 March, p345). There are increasing opportunities for pharmacists to work as QPs in both the industry and National Health Service hospitals. Introduction of the new clinical trials directive 2001/20/EC next year will require a substantial increase in the number of QPs to release investigational medical products for clinical research.

Pharmacists are ideally qualified for this work since in most cases their undergraduate degree course now contains the essential knowledge required to become a QP, which is defined in article 23 of directive 75/319. Thus a pharmacist with only 12 months' practical experience can apply for the viva to be included on the register as eligible to be a QP, although in practice a longer period of practical experience is often necessary.

Nowhere in the regulations does it state that additional training courses are required to become a QP, and in most countries of Europe it is normal practice for pharmacists to apply for recognition under the permanent provisions of the directive as soon as they complete the necessary practical experience. Only in the UK, where chemists and biologists can become QPs, is the additional training essential, since their degree courses do not include the essential topics included in the directive.

I hope that this might encourage more pharmacists to become QPs because this can be a rewarding occupation and a good means for career progression. I would not want to give the impression that I have all the answers, but should any one have any questions then I would be pleased to direct them to where their queries might be answered. Anyone wishing to contact me can do so via the Industrial Pharmacists Group at the Royal Pharmaceutical Society.

John Jolley
Norwich

QP status is difficult to achieve

From Mr M. J. D. Gamlen, MRPharmS

I read the piece "How about a career as a Qualified Person" (PJ, 19 March, p345) with some surprise. I have over 20 years' experience in the pharmaceutical industry, all of it supervising the manufacture and release of products for clinical trial use. However, the EC regulations specify that it is essential to have direct experience of production quality control and, on this basis, I and many other colleagues are precluded from QP status. I think the article would have benefited from some more direct guidance on the industrial requirements for QP training as the requirements are much more difficult to achieve than is implied.

Michael Gamlen
Beckenham, Kent

 

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