19 October 2017 — the plenary session of the Conference will be held from 9:30 to 17:30 in the conference halls «Minin» and «Pozharsky» of the hotel “Park Inn by Radisson”. Park Inn by Radisson* Yaroslavl — is the first and the only international 4-star hotel in Yaroslavl, located at: Pavlika Morozova str. 3B, Yaroslavl
20 October 2017 — sectional reports will be organized on the basis of the Center for Transfer of Pharmaceutical Technologies named after M.V. Dorogova (CTPT),
located at: Technoparkovaya Str.11 (the zone of the Yaroslavl Industrial Park), Yaroslavl
The reports of the following specialists were confirmed at the conference:
1. Federal State Budgetary Institution “Scientific Center for Expertise of Medical Products”
2. Ethics Committee of Ministry of Health of the Russian Federation
3. Federal Service for Supervision in Health Care
4. Association of International Pharmaceutical Manufacturers (AIPM)
5. Federal State Budgetary Institution of Science «Institute of Toxicology of the Federal Medical and Biological Agency»
6. LLC «ClinPharmInvest»
7. LLC «Quinta-Analytica Yaroslavl»
8. LLC «Exacte Labs» Bioanalytical Lab
9. CSU «Analytical Spectrometry»
10. Quinta-Analytica, Prague.
Reports of representatives of medical universities of the country are planned:
1. Yaroslavl State Medical University
2. Volgograd State Medical University
3. South Ural State Medical university
4. Saratov State Medical University named after V. I. Razumovsky
Special guest of the conference:
Helmut Schütz is an independent consultant in the field of bioavailability and bioequivalence studies (BEBAC), is a member of the International Pharmaceutical Federation (FIP), the European Federation for Pharmaceutical Sciences (EUFEPS), the American Association of Pharmaceutical Scientists (AAPS), the International Biometric Society (IBS), the Austrian Pharmaceutical Association (ÖPhG), the European Network for Business and Industrial Statistics (ENBIS), and the Austrian Association of Consulting Engineers (FI).
Topic of report is «Multi-Group Studies in Bioequivalence. To pool or not to pool?»
For all participants of the Conference there will be organized a free-of-charge sightseeing tour of the Center for Transfer of Pharmaceutical Technologies named after M.V. Dorogova (CTPT).
On the preliminary request of participants of the Conference, bus excursion tours around the city with professional guides (for an additional fee). It is possible to conduct excursions in English. City sightseeing tours are planned for October 19 from 18-30 to 20-30.
18 October, 2017 Clinical Research Community will hold a satellite meeting. The subject of the meeting is «Amendment to Good Clinical Practice. ICH GCP E6 R2. Application in practice «.
We will discuss all the changes that occurs in connection with the new amendment: what should be expected from the site, sponsor and CRO.
Start at 18:00, Park Inn by Radisson Yaroslavl, located at Yaroslavl, ul. Pavlik-Morozov Str.3b
Contact organizers for all questions: email@example.com or FB: https://www.facebook.com/ClinResCom/
10 main topics
1. The life cycle of innovative medicines
2. Actual normative and methodological principles of preclinical research of medicines within the framework of Eurasian Economic Union
3. Biomodeling and model selection for preclinical research
4. Experience in the examination of bioequivalence studies of drugs of analogues of endogenous compounds
5. Topical approaches to studies of bioequivalence of drugs with a narrow therapeutic range
6. Audit of research in the bioanalytical laboratory
7. Audit and inspection of the clinical center — what you need to know
8. Contemporary requirements for the formation of a registration dossier within the framework of the Eurasian Economic Union
9. Experience in certification of the laboratory center in accordance with State standard GOST 33044 «Principles of good laboratory practice» GLP.
10. Introduction of risk-based monitoring model in bioequivalence studies.
Within the framework of the Conference, plenary sessions will be organized with presentations in Russian and English, accompanied by a multimedia presentation (formats ppt, pptx, pdf), sectional lectures and speeches.
Participants of the Conference will be able to take part in the Business Game.
• Research and development of new drugs in Russia and EAEU. Substantial issues of drug researchв
• Modern requirements to the quality clinical trials in accordance with GCP and legislation in Russia and EAEU
• Modern requirements to the quality of preclinical research in accordance with GLP and legislation in Russia and EAEU
• Organization and practice of Phase I and Bioequivalence studies conduct
• Organization and conduct of Phase II – IV Clinical studies
• Bioanalytical studies of drugs in the framework of Phase I and bioequivalence clinical trials and preclinical studies
• Analysis of problems and typical errors in drug research
• Integration of new medicines research within the framework of the EAEU
The event is held under the support of the Association of modern pharmaceutical industry and innovative medicine of the Yaroslavl region