yatish gosai
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India,
2019-08-06 14:29

Posting: # 20481
Views: 565
 

 Sponsor’s Medical Expert in Bioequivalence Study [Regulatives / Guidelines]

Should the sponsor's medical expert be a registered physician for local regulation? Apart from this he or she must possesses education in allopathic medicine stream? Please opine with any guideline reference.


Edit: Please follow the Forum’s Policy[Helmut]
Helmut
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Vienna, Austria,
2019-08-07 12:05

@ yatish gosai
Posting: # 20483
Views: 450
 

 What’s a “Sponsor’s Medical Expert”?

Hi Yatish,

» Should the sponsor's medical expert be a registered physician for local regulation?

You should know your local regulation better than we do.
The term “sponsor’s medical expert” does not exist in any of the relevant ICH guidelines (E6(R2), E8(R1)). On the sponsor’s side I have seen  – apart from physicians – pharmacists, dentists, biologists, (bio)chemists, and even veterinarians. This is in line with E6(R2), which states in

5.3 Medical Expertise
The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.

(my emphasis)

Furthermore, even if the project manager (the most common term) of the sponsor – in any country  – is a physician, how likely would he/she be registered in say, India?

» Apart from this he or she must possesses education in allopathic medicine stream?

As I wrote above, no specific requirements for the sponsor. Of course, the principal investigator has to be sufficiently qualified/trained (E6(R1) Sections 2.7, 2.8, 4.1.1, and 5.6.1) and the sponsor has to assure that. The ultimate responsibility for compliance with GCP resides always with the sponsor (Section 5.2.1).
I would never ever delegate the duties of a PI to a homeopath.

Cheers,
Helmut Schütz
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