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1.
What should Merck Limited Egypt Employee do if contacted by a physician who indicated that a Merck Serono product “did not work” and asked for information ?
Send the “lack of effect” report to the local drug safety mailbox providing the information on the Technical Complaint
Inform the local responsible function to initiate the local complaint procedure
Collaborate with the local medical information function to provide a response to the physician regarding a request for information
All of the above
2.
Medical representative calls a patient to provide guidance on how use the new pre filled syringes & the patient informs the representative of a non serious Adverse Event (AE) that he experienced
This is not reportable to Local drug safety officer as it is non serious solicited AE from a consumer: True
This is not reportable to Local drug safety officer as it is non serious solicited AE from a consumer: False
3.
During patient education meeting, a consumer reports that she was taking the Company's new product and found that she became drowsy after her first dose. The physician and Merck employee
should suggest that the consumer notify the company drug safety department/medical information
are required to report this to the company drug safety department/medical information department
may report this information to the company drug safety department/medical information department
4.
As soon as the 4 criteria (reporter, identifiable patient, Adverse Event, company drug suspected) are received by any company employee. Company employee is requested to report to whom and when?
24 hr timeline to report to GDS (dedicated e-mail address: GDS@merckserono.net
12 hr timeline to report to LDSO (dedicated e-mail address: drug.safety.egypt@merckserono.net)
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