From: Ashwina Seerutun - Contractor
Sent: 08 September 2023 09:46
To: 'mso@terviseamet.ee.' <mso@terviseamet.ee.>
Subject: Enquiry about Notification and application for performance studies for Companion Diagnostics
Importance: High
Dear Sir/ madame
To gain a comprehensive understanding of the application process and notification requirements for performance studies related to companion diagnostics, we kindly request your assistance in providing
us with the following information:
-
Application Requirements: What are the necessary documents and information needed for the submission of companion diagnostics' application in
Estonia? Are there specific guidelines or templates available for preparing the application? And the fees to process the application.
-
Performance Studies Notification: What are the guidelines for notifying relevant authorities about the initiation of performance studies for companion diagnostics in
Estonia ? Are there specific timelines or deadlines for notifying authorities, and how is this process conducted?
-
Regulatory Pathway: Could you provide an overview of the regulatory pathway for companion diagnostics in
Estonia, including any applicable laws or regulations? Is there a specific regulatory body responsible for overseeing companion diagnostics' approvals and performance studies?
-
Acceptance Criteria: What are the key criteria that authorities consider when evaluating applications for companion diagnostics' approval and performance studies? Are there any specific safety or efficacy thresholds that need to be met?
-
How and To which competent authority are Serious Adverse Incidents and Other Incidents Reported? What are the timelines for reporting SAEs?
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Contact Information: Please provide the contact details of the relevant department or personnel we can liaise with for further inquiries or clarifications.
-
What are the costs involved for application and Notification to Competent Authority?
-
What are the timelines for Ethics Approval?
I
would be grateful if you could provide a list of requirements for
-
Authorization and Notification of companion diagnostic under the IVDR to competent authority in Bulgaria
-
Application to Competent Authority in Estonia
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The applicable fee for Notification and Application
-
The SAE reporting timelines.
Ashwina Lutchumun
Clinical Affairs Specialist, Global Clinical affairs Operations
QIAGEN
Sample to Insight
QIAGEN UK (Remote)
ashwina.seerutun@contractor.qiagen.com
www.qiagen.com
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