Exclusive 30-min webinar hosted by the Asia Regulatory Professionals Association showing you the clinical trial approval process, local ethics committee approval, import and export license requirements, pharmacovigilance requirements and tips to make it smoother and quicker.

Speakers:
Natalya Eliseeva, Senior Regulatory Manager at OCT Clinical
Anna Yanaeva, Head of Business Development at OCT Clinical

00:00 — Introduction
03:10 — Clinical Trial Application approval process
06:05 — Regulatory submission and Ministry of Health approval
07:54 — The list of documents for CTA submission
17:15 — Local Ethics Committees
18:45 — Import licenses
19:35 — Export licenses
20:40 — Reporting to RA during a clinical trial
22:37 — Submission to the Pharmacovigilance Authority

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