How to set up a LEMS
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1 year ago
Hi,
I am currently working with a pipeline portfolio and I think the activity I want to conduct is a LEMS. I have had a look in the ABPI code of practice but I couldn’t find much information about the considerations. Is there a guide or additional information on how to conduct this type of activity?
Yes, you are correct, there is very little information in the ABPI Code of Practice regarding the legitimate exchange of medical and scientific information during the development of a medicine (also known as LEMS). All the Code states is that ‘it is not prohibited, provided that any such information or activity does not constitute promotion…’
There is further information, although not much more, in the now archived Clause 3 Guidance, which is still available on the PMCPA website. The Guidelines on Company Procedures Relating to the ABPI Code of Practice suggests that companies should have an SOP relating to LEMS, if the company where you are working has an SOP or policy relating to LEMS this would be a good place to start. If not, then consulting the past PMCPA cases relating to LEMS would be helpful. From the past cases, some key principles are:
It you think that you have a need for LEMS and it meets the criteria in past cases or you company’s SOP/policy then it might be useful to discuss this with a final signatory in advance of commencing any work.