Moderator: Ms. Valentina KOSENKO, Deputy Head of the Federal Service for Surveillance in Public Health Sector

Themes*:

• Changes in Russian legislation. The first results of implementation of Federal Law No. 140-FZ: registration of pharmaceutical products and GMP inspections
• Standardization and quality control of pharmaceutical products. Main trends in the Russian Federation
• Scientific advice as a driver for regulatory system development
• ICH Evolution: case studies of main trends in the development of modern regulatory system in countries with ICH representation. Drug life cycle management as a global strategy and a key regulatory challenge
• Ways of convergence and standardization of regulatory systems – global associations’ example: challenges and opportunities for the regulatory system and the industry
• Procedures for a wider access to therapy – significance of quality data in the drug registration dossier. Cooperation between developers and regulators
• Transformation of the regulatory paradigm for drug quality: from the concept of a regulatory document to the Quality by Design system

Speakers*:

• Mr. Alexey Alekhin, Director of the Department for Pharmaceutical and Medical Industry
• Mr. Arsalan TSYNDIMEYEV, Assistant to the Minister of Health of the Russian Federation
• Ms. Elena Popova, Director for Regulatory Policy in Healthcare Sector, Association of International Pharmaceutical Manufacturers (AIPM)
• Mr. Pär Tellner, Director, Team Leader, Regulatory Affairs, ICH Coordinator at EFPIA
• Mr. Susanne Ausborn, Regional Manager, Regulatory Affairs, EFPIA
• Mr. Paul Stott, Vice President, Global Product Development at AstraZeneca, representative of the Expert Group for Technical Development, EFPIA

Moderators*: Mr. Vladislav SHESTAKOV, Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade, Ms. Elena POPOVA, Director for Regulatory Policy in Healthcare Sector, Association of International Pharmaceutical Manufacturers (AIPM)

Themes*:

• Particularities of pharmaceutical legislation and GMP regulation in different countries
• Harmonization of GMP assessment within PIC/S - recent trends and tendencies. Classification of non-compliances – current status and draft of PIC/S document
• International treaties on mutual recognition of GMP inspections - a review of regulatory practices
• Regulatory convergence in GMP and inspection procedures: benefits for regulators, industry and patients
• Different approaches to GMP inspections in different regulatory jurisdictions (case studies from the EU and the US)
• The impact of global regulatory approaches on regulatory compliance and development of pharmaceutical products
• Ways and opportunities for international cooperation
• Streamlining of international regulatory systems: what needs to be done?
• Opportunities for interaction at the level of trade unions and associations
• Localization of international quality standards in Russia
• Quality policies – a bureaucracy or a company’s strategic plan?

Speakers*:

• Ms. Valentina KOSENKO, Deputy Head of the Federal Service for Surveillance in Healthcare
• Mr. Roberto CONOCCHIA, Scientific Administrator EMA (European Medicines Agency)
• Ms. Isabella MAJIC, Head of the Inspectorate of HALMED (Croatia)
• Mr. Shingou SAKURAI, Head of Inspectorate, PMDA, (Japan)
• Dr. Bogdan KIRILOV, Executive Director of the Bulgarian Drug Agency
• Mr. Andrew CHANG, Vice President for Quality and Compliance, NovoNordisk, formerly FDA Policy and Regulation Deputy Director (USA)
• Mr. Mohan GANAPATHY, Executive Director for Global External Development «MSD»
• Dr. Daniela DRAGO, Director of Regulatory Affairs University of Washington (USA)
• Dr. Stephan RÖNNINGER, Director for Quality and External Relations of AMGEN
• Dr. Ulrich BECHT, Abbott Quality Assurance Director
• Ms. Anna ARUTYUNOVA, Quality Director of «Valenta Farm»

Moderator: Mr. Albert KARIMOV Deputy Prime Minister – Minister of Industry and Trade of Tatarstan

Themes*:

• Greetings from Mr. Albert Karimov, Deputy Prime Minister – Minister of Industry and Trade of Tatarstan
• Healthcare system in Tatarstan
• Commercial, industrial and investment capacity of the Republic of Tatarstan
• Experience of the «Idea Technopark» in the field of financing projects of the pharmaceutical industry (ZAO IPT Idea)
• Possible areas of cooperation (JSC «Tatkhimpharmpreparaty»)
• Scientific and academic capacity of the Republic of Tatarstan
• Dialogue with the main non-staff specialists of the Republic of Tatarstan and the Russian Federation

Speakers*:

• Mr. Marat SADYKOV – Health Minister of the Republic of Tatarstan
• Ms. Taliya MINULLINA – Head of the Tatarstan Investment Agency
• Mr. Oleg IBRAGIMOV, Acting CEO of Innovative Technology Park ‘IDEA’
• Mr. Timur KHANNANOV, CEO of TatKhimPharmPreparaty JSC
• Mr. Albert GAYFULIN, CEO of FarmMedPolis (Pharmaceutical and Medical Insurance) of the Republic of Tatarstan
• Mr. Alexey SOZINOV – Rector of the Kazan State Medical University
• Mr. Ramil KHABRIEV – Director of the National Semashko National Research Institute of Public Health
• External experts of the Health Ministry of Tatarstan and the Russian Federation (TBD)

Moderator: Ms. Elena DENISOVA, Deputy Director of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, Mr. Vladislav SHESTAKOV, Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade

Themes*:

• New tendencies in technical regulation of the EAEU good manufacturing practices
• Operational issues of the united pharmaceutical market
• Rules and procedure for conducting GMP-inspections according to the EAEU rules
• Accession of EAEU member countries to PIC/S: potential, prospects and benefits
• International cooperation of inspectorates and current inspection standards
• Kazakhstan as an example of GMP and GDP implementation
• GMP inspections according to the EAEU rules – from the manufacturer’s viewpoint. Results of the first inspection requests.
• Authorized Persons Attestation of pharmaceutical manufacturers – conditions and requirements of the EAEU

Speakers*:

• Mr. Valery KORESHKOV, Member of the Board (Minister) for Technical Regulation Eurasian Economic Commission
• Mr. Dmitriy ROZHDESTVENSKIY, Head of the Coordination Department in the field of drugs and medical products circulation of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission
• Ms. Natalia CHADOVA, Head of the Administration for Inspection of Medicines and Expertise of FSI «SID & GP»
• Mr. Nurlybek ASYLBEKOV, Deputy Chairman of the Pharmacy Committee, Ministry of Health of the Kazakhstan Republic
• Ms. Yelena STEPKINA, Head of the Administration for Implementation and Development of Good Pharmaceutical Practices and International Standards of the National Center for Expertise of drugs, medical devices and medical equipment of the Kazakhstan Ministry of Health and Social Development
• Mr. Mkrtich SHAKARYAN, Head of Inspection Department, Scientific Centre of Drugs and Medical Technology Expertise (Armenia)
• Ms. Chinara MAMBETALIEVA, Head of the Quality Assessment of Drugs and Medical Products, Department of Medicines and Medical Devices, Kyrgyzstan Health Ministry
• Ms. Natalia PYATIGORSKAYA, Member of the Professional Attestation Council in Pharmacy, Department of Industrial Pharmacy of the First Moscow Sechenov Medical University
• Mr. Viktor DMITRIEV, Director General of the Russian Pharmaceutical Manufacturers’ Association
• Ms. Yelena POPOVA, AIPM Senior Director for Regulatory Affairs and Health Policy
• Mr. Lev DUMCHEV, Head of the Eurasian Division of «Bosnalijek»

Moderator: Ms. Liliya TITOVA, CEO of the Union of Professional Pharmaceutical Organizations

Themes*:

• Labeling of medicines in Russia: the current agenda
• International regulators’ experience in implementing traceability of the medicines labeling system
• Lessons learned from the pilot project on medicines labeling. Main conclusions and preparedness of participants of the production and logistics chain
• Mandatory labeling in the Russian Federation. Current status quo and implementation milestones

Speakers*:

• Ms. Valentina KOSENKO, Deputy Head of the Federal Service for Surveillance in Healthcare
• Ms. Elena DENISOVA, Deputy Director of Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
• Ms. Tatiana NIKOLKO, Deputy Head of the Administration for Pharmaceuticals Production Inspection and Expertise of the State Institute of Drugs and Good Practices
• Mr. Roberto CONOCCHIA, EMA representative (European Medicines Agency)
• Mr. Álvaro Israel Pérez VEGA, Public Health Officer, Federal Commission for Healthcare Risk Prevention COFEPRIS
• Mr. Domenico di GIORGIO, Head of Inspection and Certification Department, Italian Medicines Agency (AIFA)
• Mr. Anton KHARITONOV, Head of the «Pharma» line of the Advanced Technologies Development Center
• Mr. Joseph TRAPLE, Head of the Global Technologies GMS of Takeda Pharmaceuticals International
• Mr. Andrey AKHANTYEV, Head of Economic Security, GEROPHARM company
• Mr. Eugeniy BELOV, Head of the Department of Technology Projects «Bayer»
• Mr. Dmitriy BAGLEY, Business Analyst of the Office of Federal Projects of JSC «CentreInform», Head of Project Management Department, IT Department, CJSC «Medsi Group»

Moderator: Ms. Rimma ABRAMOVICH, ISPE EEU Director, Director of the Center for Collective Use (Scientific and Educational Center), Head of the Department of Pharmaceutical Technology, Department of Advanced Training of Medical Employees of the Peoples’ Friendship University of Russia

Themes*:

• Production Transfer
• Issues of technical regulation and standardization of manuals and rules for the design and organization of production
• Organization of interaction between professionals in the pharmaceutical industry for the best results achievement
• Modern API manufacturing
• Articulation of Pharma 4.0 concept. Trends` review
• Industry 4.0 and Russian realities

Speakers*:

• Mr. Josef KRIEGL, Chemgineering, member of the advisory board for the ISPE DACH (Deutschland, Austria, Switzerland)
• Mr. Igor FALKOVSKY, Head of the Department of Good Engineering Practices of the FSI «SID & GP»
• Mr. Achim LUKEL, Head of Global Quality Compliance of Solid Forms, Novartis
• Dr. ZIV DEE NOOR, Leading API expert, Head of Life Science Activity Baran Group Ltd.
• Mr. Dmitriy POLSTYANOV, Director General, LLC «IKS-TECH»
• Mr. Louis TURCOTT, Vice President, Pharmaceutical Division, OPTEL GROUP
• Mr. Zdenek PAVELEK, Head of Quality and Training Department, FAVEA Group
• Mr. Sergey MOVSESOV, Head of Pharmaceutical Projects, BWT Russia
• Mr. Aleksey TOPNIKOV, CEO of G.M. Proekt-Rus

Moderator: Mr. Vladislav SHESTAKOV, Director of the State Institute of Drugs and Good Practices

Tasks*:

• Participants’ voting on discussed issues
• Summarizing results of the Conference
• Video backdrop of the Conference presented by PharmVestnik TV
• Closing remarks from Mr. German INOZEMTSEV, Chief Editor of the publishing house Phjarmaceutical Vestnik

Moderator: Ms. Elena DENISOVA, Deputy Head of the Department of Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, Ms. Nataliya CHADOVA Head of the Department for Inspection of Drug Production and Expertise of the FSI «SID & GP»

Themes*:

• GMP audit management
• Results of inspection of Russian and foreign pharmaceutical manufacturers
• Current inspection issues: major deviations revealed during inspections, CAPA related issues
• Russian GMP-inspections of foreign manufacturers through the eyes of an independent consultant
• Follow-up GMP inspections of manufacturers (case study)

Experts*:

• Ms. Yulia GRISHINA, Deputy Head of the Department for Inspection of the Production of Medicinal Products of the FSI «SID & GP»
• Mr. Vladimir ORLOV, Deputy Head of the Department of Scientific and Methodological Work and Training of the FSI «SID & GP»
• Mr. Ivan GULYAEV, Chief specialist of the Department of Inspection of the Production of Medicinal Products of the FSI «SID & GP»
• Ms. Agnes SZABO, GMP inspector, National Institute of Pharmacy and Nutrition (OGYÉI)
• Mr. Kris EVANS, Executive Director, Quality Sciences at Amgen Inc. (former Senior Regulatory Officer, US FDA)
• Mr. Najib SEHAT, Head of International Regulatory Department, Life Science Division at «Merck»
• Ms. Luba SKIBO, President, Chief Consultant of Skibo Regulatory Consulting Consulting
• Ms. Anna ARUTYUNOVA, Quality Director of «Valenta Farm»
• Ms. Olga MAKLAKOVA, Quality Director «Akrihin Staraya Kupavna»
• Ms. A. VASILYEVA, Head of the TEVA Registration Group
• Ms. Biorkys Yanez CHAMIZO, Head of GMP inspectorate, CECMED

Moderator:Ms. Natalia ALADYSHEVA, Deputy Head of the Division for Pharmaceutical Licensing and Inspections of the Russian Ministry of Industry and Trade

Themes*:

• Issues of licensing the production of certain groups of drugs
• Calibration check-up. Metrology system for Measurement systems at pharmaceutical production site
• Licensing of nuclear medicine facilities. International practice
• Production of AFI for Radio Pharm Medicines
• Requirement for the development of new Radio Pharm Medicines

Experts*:

• Ms. Vera BOGDANOVA, Adviser to the Director General of the FMBA of Russia FSBI «Rosplazma»
• Mr. Alexey MARTYNOV, Member of the Expert Council of the Agency for Strategic Initiatives (ASI), General Director of HOMEXPHARM
• Ms. Elena ZELINSKAYA, GMP-expert of IBA (Russia)
• Mr. Miguel Angel Sancho ALPAÑES, GMP inspector, Spanish Agency of Medicines and Medical Devices
• Dr. Franz SCHONFELD, GMP & GDP State Inspector (Germany)
• Mr. Egor RYBAKOV, Specialist of the Department of Inspection of the Production of Medicinal Products of the FSI «SID & GP»

Moderator: Mr. Igor FALKOVSKY, Head of the Department of Good Engineering Practices of the FSI «SID&GP»

Themes*:

• Presentation of the Industry Data Integrity Guide
• Data integrity management: stages and metrics in the world practice
• Practical approach to data integrity assessment and CAPA
• System implementation case study

Experts*:

• Ms. Gilda D'INCERTI, General Director of PQE
• Mr. Roberto BERTINI, PQE Operations Director and Partner
• Mr. Anton VILLY, Counselor in the Strategic Planning Division of the Global Quality Unit, Novartis