AUTH/3083/9/18: Director v Eisai — Clinical trial disclosure (outwith scope; no breach) | PMCPA Case

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Key facts

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Case number	AUTH/3083/9/18
Parties	Director v Eisai
Topic	Clinical trial disclosure
Complaint received	12 September 2018
Completed	03 July 2019
Applicable Code year	2016
Outcome	No breach (outwith the scope of the Code)
Clause(s)	Outwith the scope of the Code
Appeal	No appeal
Additional sanctions	Not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A complaint was brought by the PMCPA Director against Eisai.
The subject matter related to clinical trial disclosure.
The PMCPA determined the matter was outwith the scope of the ABPI Code (Applicable Code year: 2016).

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No breach (outwith the scope of the Code).
No case summary published (recorded as “No summary, outwith the scope of the Code”).
No case report published (recorded as “No case report, outwith the scope of the Code”).
No appeal.

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