The only international event dedicated to discussing regulatory, ethical and operational aspects of running clinical trials in Russia

26-27 November 2019

InterContinental Moscow Tverskaya Hotel

First speaker confirmations in 2019

Konstantin Binko, Deputy Director of the Department for Pharmaceutical Drug Provision and Regulation of the Circulation of Medical Devices, Ministry of Health of the Russian Federation
Konstantin Binko

Deputy Director of the Department for Pharmaceutical Drug Provision and Regulation of the Circulation of Medical Devices

Ministry of Health of the Russian Federation

Dmitry Rozhdestvensky, Head, Division for Coordination of Common Market for Drugs and Medical Devices Formation, Eurasian Economic Commission
Dmitry Rozhdestvensky

Head, Division for Coordination of Common Market for Drugs and Medical Devices Formation

Eurasian Economic Commission

Gulmira Ormanova, Chief Expert, Methodology and Internal Administration Division, Department of Technical Regulation and Accreditation, Eurasian Economic Commission
Gulmira Ormanova

Chief Expert, Methodology and Internal Administration Division, Department of Technical Regulation and Accreditation

Eurasian Economic Commission

Natalja Karpova, Senior Expert, Efficacy and Safety Division of Medicines Marketing, Authorization Department, State Agency of Medicines (The Republic of Latvia)
Natalja Karpova

Senior Expert, Efficacy and Safety Division of Medicines Marketing, Authorization Department

State Agency of Medicines (The Republic of Latvia)

Francis Crawley, Executive Director, Good Clinical Practice Alliance - Europe (GCPA), Belgium
Francis Crawley

Executive Director

Good Clinical Practice Alliance - Europe (GCPA), Belgium

Victoria Kosmacheva, Clinical Research Director, Non-Foot Print Countries, GSK
Victoria Kosmacheva

Clinical Research Director, Non-Foot Print Countries

GSK

Alexander Obukhov, Head of Medical Department, Pharmstandard
Alexander Obukhov

Head of Medical Department

Pharmstandard

Sergey Dubrovin, Site Relationship Partner (Director), Russia and Belarus, Pfizer
Sergey Dubrovin

Site Relationship Partner (Director), Russia and Belarus

Pfizer

Mikhail Samsonov, Chief Medical Officer, R-Pharm
Mikhail Samsonov

Chief Medical Officer

R-Pharm

Konstantin Gudkov, Clinical Research Director, AstraZeneca Russia
Konstantin Gudkov

Clinical Research Director

AstraZeneca Russia

Vladimir Bulatov, Chief Scientific Officer, Novartis Pharma, Russia
Vladimir Bulatov

Chief Scientific Officer

Novartis Pharma, Russia

Olga Melnik, Head of Clinical Operations, Novartis Pharma
Olga Melnik

Head of Clinical Operations

Novartis Pharma

Marina Debryanskaya, Head of Clinical Trials Management, Russian Innovation Centre, Takeda Pharmaceuticals
Marina Debryanskaya

Head of Clinical Trials Management, Russian Innovation Centre

Takeda Pharmaceuticals

Tatiana Goldina, Data Generation & Scientific Communication Lead, Medical Affairs, Sanofi
Tatiana Goldina

Data Generation & Scientific Communication Lead, Medical Affairs

Sanofi

Alexander Andreev, Clinical Trials Director, Russia & EAEU countries, Servier
Alexander Andreev

Clinical Trials Director, Russia & EAEU countries

Servier

Roman Drai, Director, Clinical Development, GEROPHARM
Roman Drai

Director, Clinical Development

GEROPHARM

Maria Leer, Head of Medical Projects Group, Takeda
Maria Leer

Head of Medical Projects Group

Takeda

Andrei Khitriy, Head of Biostatistics, Synergy Research Group
Andrei Khitriy

Head of Biostatistics

Synergy Research Group

Natalia Vostokova, Chief Operating Officer, IPHARMA
Natalia Vostokova

Chief Operating Officer

IPHARMA

Grigory Kolesnikov, IT Business Partner Pharmaceuticals, Bayer
Grigory Kolesnikov

IT Business Partner Pharmaceuticals

Bayer

Vladimir Vasilyev, Compliance Process, Training & Systems Manager, PDG Country Clinical Operations, CEETRISMEA, F.Hoffmann-La Roche Ltd.
Vladimir Vasilyev

Compliance Process, Training & Systems Manager, PDG Country Clinical Operations, CEETRISMEA

F.Hoffmann-La Roche Ltd.

Yuri Zhulev, Co-Chairman, Russian Patients Association
Yuri Zhulev

Co-Chairman

Russian Patients Association

Elena Lukina, Head of the Department of Orphan Deseases , National Research Centre for Hematology
Elena Lukina

Head of the Department of Orphan Deseases

National Research Centre for Hematology

Mikhail Maschan, Director of High School of Molecular and Experimental Medicine, Dmitry Rogachev National Research Center
Mikhail Maschan

Director of High School of Molecular and Experimental Medicine

Dmitry Rogachev National Research Center

Nikolay Zhukov, Head of the Department for Optimization of Treatment for Adolescents and Young Adults with Oncological Diseases, Rogachev Federal Scientific and Clinical Centre of Pediatric Hematology Oncology and Immunology
Nikolay Zhukov

Head of the Department for Optimization of Treatment for Adolescents and Young Adults with Oncological Diseases

Rogachev Federal Scientific and Clinical Centre of Pediatric Hematology Oncology and Immunology

Tatiana Zhiganova, Head of Translational and Cell Research Department, Rogachev Federal Scientific and Clinical Centre of Pediatric Hematology Oncology and Immunology
Tatiana Zhiganova

Head of Translational and Cell Research Department

Rogachev Federal Scientific and Clinical Centre of Pediatric Hematology Oncology and Immunology

Dmitriy Karateev, Rheumatologist, Cheif Rheumatologist of the Ministry of Health of Moscow Region, Head, Moscow Regional Rheumatololgist Centrer
Dmitriy Karateev

Rheumatologist, Cheif Rheumatologist of the Ministry of Health of Moscow Region, Head

Moscow Regional Rheumatololgist Centrer

Natalia Krasnopeyeva, Endocrinologist, Russian Railways Clinical Hospital, Chelyabinsk
Natalia Krasnopeyeva

Endocrinologist

Russian Railways Clinical Hospital, Chelyabinsk

Artem Poltoratskiy, Head of the Department for Pre-Clinical and Clinical Trials, National Medical Research Centre of Oncology Named after N.N.Petrov
Artem Poltoratskiy

Head of the Department for Pre-Clinical and Clinical Trials

National Medical Research Centre of Oncology Named after N.N.Petrov

Olga Bolshakova, Head, Scientific Research Laboratory of Clinical Trials and Evidence-Based Medicines of Preclinical and Clinical Research Centre, Almazov National Medical Research Centre
Olga Bolshakova

Head, Scientific Research Laboratory of Clinical Trials and Evidence-Based Medicines of Preclinical and Clinical Research Centre

Almazov National Medical Research Centre

Pavel Kholkin, Director of Data Management, IPHARMA
Pavel Kholkin

Director of Data Management

IPHARMA

Evgeny Rogov, Independent GCP / GLP Auditor,
Evgeny Rogov

Independent GCP / GLP Auditor

Alexey Ladutko, Head of Scientific Department, Smooth Drug Development
Alexey Ladutko

Head of Scientific Department

Smooth Drug Development

Marina Guryleva, Chairman of the Local Ethical Committee , Kazan State Medical University
Marina Guryleva

Chairman of the Local Ethical Committee

Kazan State Medical University

Konstantin Penkov, Oncologist, Russian Railways Clinical Hospital (Saint Petersburg)
Konstantin Penkov

Oncologist

Russian Railways Clinical Hospital (Saint Petersburg)

Alina Agafina, Head of Clinical Research Department, City Hospital N40, Sestroretsk
Alina Agafina

Head of Clinical Research Department

City Hospital N40, Sestroretsk

Elmira Nurasheva, Head of the Clinical Research Materials Examination Department, National Centre for Expertise of Medicines and Medical Devices (Kazakhstan)
Elmira Nurasheva

Head of the Clinical Research Materials Examination Department

National Centre for Expertise of Medicines and Medical Devices (Kazakhstan)

Aliya Tabayeva, Coordinator of the Department for Pharmacological Expertise of Pharmaceutical Drugs, National Centre for Expertise of Medicines and Medical Devices (Kazakhstan)
Aliya Tabayeva

Coordinator of the Department for Pharmacological Expertise of Pharmaceutical Drugs

National Centre for Expertise of Medicines and Medical Devices (Kazakhstan)

Yulia Potapova, Senior Manager Development Operations, Amgen
Yulia Potapova

Senior Manager Development Operations

Amgen

Topics for discussion in 2019

• Future of clinical trials: development trends globally and in Russia
• Clinical trials in the Eurasian Economic Union: common rules in action
• Digitalization in clinical trials: AI, portable devices, electronic registers, switch to electronic patient consent
• Improving quality of clinical studies: point of view of various stakeholder groups
• Patient engagement in clinical trials
• Early access for medicines to the market: features of early phases of clinical trials
• Non-interventional post-registration studies: development trends
• Investigator initiated clinical trials: distinguishing features, challenges and opportunities
• Biostatistics and data management
• Clinical trials of pharmaceutical drugs for rare diseases: ways to improve effectiveness
• Clinical trials of gene and cell therapy drugs: what to expect?
• Clinical trials of drugs used in life-threatening diseases
• Collaboration between a sponsor and investigator centres: transformation in the era of technological changes

Why to attend the Clinical Trials in Russia Forum in 2019?

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Insights from 40+ experts: regulators, representatives of international and Russian pharmaceutical producers, CROs and investigators

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2-day information-rich programme that includes insightful presentations from leading sector players, interactive debates and round tables

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Unrivalled networking opportunities with 150+ attendees from such companies as AstraZeneca, Pfizer, Novartis, Bayer, Biocad, R-Pharm and many more

FEEDBACK FROM ATTENDEES

Unique opportunity for all the clinical trials sector players to meet and discuss the most burning issues.

Tatiana Minakova,

Associate Director, Clinical Monitoring, Syneos Health

The forum brings together representatives of all stakeholder groups involved in clinical trials – sponsors, CROs, regulators and investigators for a constructive dialogue aimed at improving all future processes.

Julia Semenova,

Pharma Development Unit Head, Novartis Russia

Very good overview of a large number of clinical trial topics and the specifics of the Russian market.

Henryette Schatt,

JDirector eCOA Business Development, ERT (Switzerland)

Very interesting insight into the latest developments in the Russian market.

Stefanie Rau,

Clinical Trials and Pharmacovigilance Manager Europe, MUCOS Pharma (Germany)


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