What you’ll learn
- How to get your clinical trial approved in Russia and Eastern Europe
- What Clinical Trial Approval process for different types of studies and therapeutics areas look like
- How to submit a Clinical Trial Approval Application
- What are the 3 main stages for clinical trial initiation in Russia
- How long does it take to get a clinical trial for your drug to be approved in Russia
- How to ensure that you get your CTA approved within desired timelines
Requirements
- No prior knowledge is needed
Description
A 30 mins video showing you the clinical trial approval process, local ethics committee approval, import & export licence requirement, pharmacovigilance requirement and tips to make it smoother or quicker. Sharing by experts from OCT Clinical.
Who this course is for
- Regulatory Managers
- Biotech startup staff and leadership
- CEOs
- Heads of clinical operations
- Directors of clinical trial management
- Directors of research and development
- Clinical trials managers
- Chief scientific and medical officers
- Vice presidents of clinical operations and development
- Procurement managers
- Clinical outsourcing managers
About the trainers/speakers
- Natalya Eliseeva, Senior Regulatory Manager, OCT Clinical (https://oct-clinicaltrials.com/)
- With over 10 years of experience in clinical trials Natalya coordinates the work of the regulatory department, ensures that trials are carried out in accordance with applicable legislation and regulations, and makes sure that regulatory submissions meet all applicable requirements and are prepared in accordance with the highest quality standards.
- Anna Yanaeva, Head of Business Development, OCT Clinical (https://oct-clinicaltrials.com/)
- Anna is ensuring efficient communication with OCT clients and Sponsors on all aspects of study planning, including study budget preparation. With over 8 years of experience in clinical research, Anna keeps building long-term and secure relationships with OCT partners and clients.
Approximate course length
- 0.5 hour
