Regulatory Affairs, CMC and GMP in Russia

Detailed programme Day 1+2: 09:00 am - 4:00 pm
Day 3: 09:00 am - 4:00 pm
09:00 Reception and introduction round
09:15 Edelgard Rehak Registration of medicines in RU, KZ, BY, UA and UZ

Comparative overview of current regulatory developments in the CIS region

Degree of regulatory harmonisation with ICH, WHO, PIC/S and EU regulations

New submissions

Maintenance of registrations

10:45 Coffee break
11:00 Edelgard Rehak Basic principles of registrations (EAEU)

Legal framework

Authorities

12:15 Lunch break
13:00 Galina Senchukova Russia - A regulatory overview I

Authorities, registration process

Interchangeability, PIL/SmPC

Maintenance of registrations

13:45 Coffee break
14:00 Galina Senchukova Russia - A regulatory overview II

CTD dossier and electronic submission

Serialisation

Latest changes in FL 61

16:00 End of training day 1
09:00 Galina Senchukova CMC documents for marketing authorisation in detail

Module 3 and the normative document

Certificate of analysis

Relevance of Russian Pharmacopoeia

Regulatory impact of site transfer

Localisation of production

10:30 Coffee break
10:45 Continuation: CMC documents for marketing authorisation in detail
11:30 Galina Senchukova Official batch release procedure

Regulatory and quality requirements

For "pharma" products

For immunobiological products

12:00 Lunch break
13:00 Edelgard Rehak Regulatory framework in the Eurasian Custom Union (EAEU) between RU, KZ, BY, AM, KG - overview

First experiences with new submissions (MRP/DCP)

Dossier upgrade procedure

Status of harmonisation (Phamacopeia, GMP)

Variations and maintenance

e-CTD practical advice

16:00 End of training day 2
09:00 Reception and introduction round
09:15 Galina Senchukova GMP inspections by authorities in Russia, Kazakhstan, Belarus and EAEU

Regulations and costs

Recognition of GMP, PIC and CIS countries

Site preparation

10:45 Coffee break
11:00 Galina Senchukova Challenges of GMP inspections by Russian authorities

GMP inspection peculiarities in Russia: agenda, cultural differences, language, etc.

Change Management

Handling regulatory non-compliance in GMP inspections

Handling rejections of GMP inspections: industry experiences

12:15 Lunch break ...