The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Seminar 23-24 November 2017 «Questions of 4-5 Modules of Registration Dossier formation»

FSI «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation conducts a training seminar on «Questions of 4-5 Modules of Registration Dossier formation».

The seminar will highlight the current issues of the Eurasian legislation in the sphere of medicines circulation. Issues of the registration dossier formation in the format of the General Technical Document (GTD) in the part of modules 4 and 5 documents and their interrelation with the module 2 of the registration dossier.

The questions of the modules composition and the peculiarities of the documents locations will be considered when forming the structure of GTD. The features of the reporting documentation of each module, its composition depending on the type claimed for the registration of a medicine (original remedy, generic, hybrid and bioanalogical medicines) are analyzed.

Upon the seminar completion, the participants will receive the certificates of participation. 

The seminar will be conducted by Dmitriy Rozhdestvenskiy, Head of the Coordination Department in the field of circulation of drugs and medical products of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission.

Seminar programme

23 November
10.00 – 12.00 Normative base of the Eurasian Economic Union market: the hierarchy of normative acts of the Eurasian Economic Commission, the EAEU Pharmacopoeia, the development of the Union new acts. Applicable registration procedures and major transitional periods. Specialists participating in registration dossier preparation – requirements and documents.
12.00 — 13.00              Lunch
13.00 — 14.00 General principles of the registration dossier modules formation in the CTD EAEU model. Type of dossier submission.
14.00 — 15.00 Module 2 of the registration dossier. Principles of its formation and interrelation with modules 4 and 5 of the registration dossier.
15.00 — 15.10                  Break
15.10 — 17.00 Features of module 4 of the registration dossier formation: general approaches (module structure, normative documents, regulating composition and features of research, reporting requirements, information sources, location of documents in the module).
24 November
09.00 -12.00 Methodological issues of the registration dossier module 4 formation: special cases and reporting documentation (concept and system of preclinical research, the volume of studies for particular cases, assessment of the pharmacological, toxicological and pharmacodynamic profile of a medicine, features of preclinical research and formation of a module for bio-analogs).
12.00 — 13.00              Lunch
13.00 – 14.00 General principles of the registration dossier module 5 formation. Structure of the registration dossier module 5 and documents location. Documents that determine the requirements for the reporting documentation.
14.00 — 15.00 Particular principles of the registration dossier module 5 formation for generics, hybrid drugs and bio-analogs: the choice of reference drugs and its rationale, the use of biowaiver procedures for generics. Requirements for bioequivalence research reports.
15.00 — 15.10                  Break
15.10 — 16.30 Particular principles of the registration dossier module 5 formation for generics, hybrid, bioanalogical medicines: features of the reporting documentation for bioanalogical agents (basic mistakes in research planning, documentation of immunogenicity, transfer of evidence).

 

Venue: to be confirmed

Contact person: Ekaterina Ryzhikova

E-mail: ekaterina.ryzhikova@sbmrussia.com

Phone: +7 (915) 455-65-78