* * * * * AMENDMENT NUMBER 24 CLAUSE 21 SCIENTIFIC SERVICES – Clause 21.2 Current text must also have a scientific service to deal with the approval and supervision of ‘Companies studies. This scientific service must include a registered medical practitioner or, where appropriate, a pharmacist, who will be responsible for the oversight of non-interventional studies (including the review of any responsibilities relating to such studies, particularly those given to medical representatives). That person must state in writing that he or she has examined the protocol relating to the non-interventional study and that in his or her belief it is in accordance with the requirements of the Code.’ Proposal Delete the words appropriate’ before pharmacist’ and add registered’ before ‘where ‘a ‘UK pharmacist. Reason Adding registered’ before be consistent with Clause 14. ‘UK ‘pharmacist’ The EFPIA HCP Code uses the phrase or where appropriate, a pharmacist However, ‘… …’. there are no criteria upon which to decide as to when the use of a pharmacist in this context is appropriate. * * * * * AMENDMENT NUMBER 25 Clause 21.3 Current text must disclose details of clinical trials in accordance with the Joint Position on the ‘Companies Disclosure of Clinical Information via Clinical Registries and Databases and the Joint Position on the Publication of Clinical Results in the Scientific Literature.’ The supplementary to Clause 21.3 states: clause requires the provision of details about ongoing clinical trials (which must be ‘This registered within 21 days of initiation of patients enrolment) and completed trials for medicines
* * * * * AMENDMENT NUMBER 24 CLAUSE 21 – SCIENTIFIC SERVICES Clause 21.2 Current text ‘Companies must also have a scientific service to deal with the approval and supervision of studies. This scientific service must include a registered medical practitioner or, where appropriate, a pharmacist, who will be responsible for the oversight of non-interventional studies (including the review of any responsibilities relating to such studies, particularly those given to medical representatives). That person must state in writing that he or she has examined the protocol relating to the non-interventional study and that in his or her belief it is in accordance with the requirements of the Code.’ Proposal Delete the words ‘where appropriate’ before ‘a pharmacist’ and add ‘UK registered’ before pharmacist. Reason Adding ‘UK registered’ before ‘pharmacist’ be consistent with Clause 14. The EFPIA HCP Code uses the phrase ‘… or where appropriate, a pharmacist …’. However, there are no criteria upon which to decide as to when the use of a pharmacist in this context is appropriate. * * * * * AMENDMENT NUMBER 25 Clause 21.3 Current text ‘Companies must disclose details of clinical trials in accordance with the Joint Position on the Disclosure of Clinical Information via Clinical Registries and Databases and the Joint Position on the Publication of Clinical Results in the Scientific Literature.’ The supplementary to Clause 21.3 states: ‘This clause requires the provision of details about ongoing clinical trials (which must be registered within 21 days of initiation of patients enrolment) and completed trials for medicines
Code%20Proposals%20for%20consultation%20-%20final.docx