Marketing Authorisation Application procedures
in the Eurasian Economic Union

Online-training, March, 23 / March, 30 *
* The training will be held twice: on March 23 and 30.
Choose the most convenient date for you.

Registration

Program

Training program

March, 23 / March, 30
11:00 - 15:00 (CEST, GMT+1)

1. Documents founding the Single EAEU pharmaceutical market

Similarity and dissimilarity with the EU documents

2. Main procedures

Marketing authorization: mutual recognition procedure and decentralized procedure

Harmonisation procedure

Abbreviated MAA procedures

Orphan designation

Variation procedures

Renewal

3. Local requirements

Local clinical trials

Local GMP

Local Pharmacopoeia

The normative document

Pre-authorisation lab testing

Product information: PL user testing

4. EAEU regulatory classification of applications and medicinal products

New/stand-alone applications

Extension applications

Generics, hybrids, biosimilars

Combination products, well-established use, informed consent, mixed MAAs

Radiopharmaceuticals, blood products, vaccines

Herbal and homeopathic products

5. Communication between national competent authorities of the Member States during procedures and related problems

IT-communication problems

Personal communication problems

Quasi-eCTD

Speaker

Ravil Niyazov

Regulatory Affairs and Drug Development Specialist
Center for Scientific Advice Ltd.

Regulatory affairs and drug development consultant. Main focus on early and intermediate development. Cross-sectional topics such as quality/non-clinical, non-clinical/clinical, manufacturing/clinical, development and regulatory strategies

Registration

Price:
1 participant from the company - 300 Euro
2 participants - 450 Euro
3 participants - 600 Euro
4 participants - 750 Euro