Belarus

Clinical Trial Application	Belarus Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. Only one state insurance carrier in Belarus.
Standard Limits	20.000 €/patient Limit per protocol = 20.000 x number of patients
Tail Coverage	n/a
Data Required to Quote	• Clinical Trial Quote Request • LAST Protocol and Informed Consent Form in Russian • Patient Information Sheet in Russian • Investigator Brochure in Russian • Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) • Sponsor Banking Details or Premium Wire Confirmation • Three (3) years of claims history for harm caused or reimbursement of injured parties while carrying out clinical studies in Belarus. If no claims, please provide the following on your company letterhead, signed and dated: "We confirm that in the last three years (name of Sponsor) did not incur any claims related to clinical trials." • Site List of clinical sites in Belarus, if the MoH approval letter is unavailable Please allow additional time for processing. Typically up to 3 weeks for issuance of documents Belarus requires payment and payment confirmation documentation PRIOR to release of certificate. No refund for policy cancellation. A letter of guarantee can be provided in order to obtain the necessary MoH approval.

Clinical Trial Application	Italy Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	For Medical Device studies limits are: 1.000.0000 €/patient 2.5 to 10.000.000 €/protocol depending upon the size of the trial For Drug Studies limits will depend on the number of patients : 5.000.000 €/protocol up to 50 patients 7.500.000 €/protocol from 51 to 200 patients 10.000.000 €/protocol for more than 200 patients
Tail Coverage	For Medical Device Studies: 2 years (up to 5 years potentially available) For Drug Studies: => Successor liability: The Damage (bodily injury) must occur within 24 months after the end of the study => Extended reporting period: A Claim must be made by a patient within 36 months after the end of the study If the study involves gene therapy, cellular therapy, radio-pharmaceuticals or children, carriers are required to issue policies with tail coverage of at least 10 years. For the latter i.e. children, carriers issue 10 years irrespective if the study also involves adults
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Italian • Site List is preferable in Italian, but English is acceptable, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents.