Regulatory Affairs and GMP compliance in Eastern Europe - Considerations for the EAEU and Non-EAEU markets

Die Themen

- Regulatory Framework and Requirements - Approval Processes and Documentation - Product Management and Maintenance - Quality Management and GMP Audits - International Markets and Opportunities

Ziele

This seminar is designed to provide a thorough understanding of the regulatory framework and practical requirements for the registration, maintenance, and variation of medicinal products in the Eurasian Economic Union (EAEU). It also addresses critical aspects such as compliance with GMP standards, handling specific requirements for biologicals, and exploring regulatory opportunities in non-EAEU markets.

- The seminar aims to equip participants with the knowledge and tools to manage applications, variations and audits efficiently while ensuring adherence to EAEU standards and guidelines.

Wer sollte teilnehmen?

This seminar is primarily intended for those:
- Dealing with regulatory affairs or CMC in EAEU countries
- Preparing for and/or attending GMP inspections in these regions
- Managing product registrations, renewals, and variations in the EAEU.

- Regulatory affairs, CMC, quality, pharmacovigilance and business development staff will particularly benefit from this seminar. It is also highly relevant for professionals involved in clinical trials, technical documentation, and market access in EAEU and non-EAEU countries.

- This seminar is tailored for both experienced professionals seeking to deepen their understanding and newcomers aiming to gain essential insights into EAEU regulatory requirements.