yatish gosai
☆    

India,
2019-08-06 16:29
(1696 d 04:26 ago)

Posting: # 20481
Views: 2,338
 

 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
★★★
avatar
Homepage
Vienna, Austria,
2019-08-07 14:05
(1695 d 06:49 ago)

@ yatish gosai
Posting: # 20483
Views: 1,864
 

 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
87 visitors (0 registered, 87 guests [including 11 identified bots]).
Forum time: 19:55 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5