III Всероссийская GMP-конференция | Сonference program 2018
Сonference program 2018
August 27, Day One
REGULATORS` DAY
Venue: Business center at «Korston Club Hotel» Kazan, ul. Nikolaya Yershova, d. 1
8:00-10:00
Registration, welcome coffee
10:00–11:00
OPENING CEREMONY OF THE III ALL-RUSSIA GMP CONFERENCE
Venue: Big Hall, 2nd floor
Moderator: Mr. Vladislav SHESTAKOV, Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade
Official part*:
  • Welcome address by Albert KARIMOV, Minister of industry and trade of the Republic of Tatarstan
  • Welcome address by Viktor YEVTUKHOV, State Secretary – Deputy Minister of Industry and Trade of the Russian Federation
  • Welcome address by Valentina KOSENKO, Deputy Head of the Federal Service for Surveillance in the Healthсare of the Russian Federation
  • Welcome address by Dmitry MEZENTSEV, member of the Council of Federation of the Federal Assembly of the Russian Federation, Chairman of the Federation Council Committee on Economic Policy, Chairman of the Russian-Chinese Friendship Society, Representative from the Sakhalin Oblast.
  • Welcome address by Valery KORESHKOV, Member of the Board (Minister) for Technical Regulation of the European Economic Commission
  • Welcome address by Arsalan TSYNDIMEYEV, Assistant to the Minister of Health of the Russian Federation
11:00–11:15
Break
PLENARY SESSION
11:15–12:45
Drivers of pharmaceutical market growth. Global perspective
Venue: Big Hall, 2nd floor
Moderator: Mr. Vladimir SHIPKOV, Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM)
Themes*:
  • Effective state regulatory solutions as drivers of the industry development
  • New opportunities for the pharmaceutical industry: a project-based approach in the Republic of Tatarstan
  • Interaction between government agencies as the key instrument for successful industry development
  • Tools for pharmaceutical production development in Moscow
  • Cutting-edge technologies in the pharmaceutical industry: investments and outcome
  • Digital transformation of the pharmaceutical industry and good practices system
  • Review of international experience in development of the pharmaceutical market
Speakers*:
  • Mr. Albert Karimov, Minister of Industry and Trade of Tatarstan
  • Ms. Valentina KOSENKO, Deputy Head of the Federal Service for Surveillance in Healthcare
  • Mr. Aleksey Alekhin, Head of the Department of Pharmaceutical and Medical Industry Development
  • Kristina VOLOKNITSKAYA, Deputy Head of the Moscow Department for Science, Industrial Policy, and Entrepreneurship
  • Mr. Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade
  • Mr. Petr Rodionov, CEO of GEROPHARM Group
  • Mr. Alexander Kuzin, Managing Director of NovaMedica, member of the Expert Panel in the State Duma Committee for pharmaceutical circulation, development of pharmaceutical and medical industry
  • Mr. Vadim Vlasov, President of Novartis Group in Russia, Novartis Regional Manager for the Eastern Europe and CIS republics
12:45–14:00
Break
PANEL DISCUSSION
14:00–16:00
Pharmaceutical industry of the Future. Government and business perspectives
Venue: Big Hall, 2nd floor
Moderator: Mr. Dmitriy SHEIMAN, CEO «Pharmstrategy»
Themes*:
  • The «Pharma-2030» strategy. Pharmaceutical industry’ perspectives
  • Formation of the single market strategy as a factor of the Russian pharmaceutical market growth stimulation. Future capacity.
  • Educational system and talent pool. Development paradigms.
  • Export potential. Forecasts for the pharmaceutical industry development
  • Market Access from commercial and public angles. Overlapping interests and contradictions
  • A joint program to promote the best practices in the Russian pharmaceutical industry
Speakers*:
  • Mr. Alexey ALEKHIN, Director of the Department for Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation
  • Mr. Igor NARKEVICH, Rector of the St. Petersburg State Chemical and Pharmaceutical Academy
  • Mr. Ilshat GAFUROV, Rector of the Kazan Federal University
  • Ms. Roza YAGUDINA, Educational Center Director of the Scientific Centre for Expert Evaluation of Medicinal Products of the Russian Health Ministry
  • Mr. Vadim KUKAVA, Executive Director of Innovative Pharma Business Association
  • Mr. Matthias WERNICKE, Director General of Merck Biopharma Russia & CIS
  • Mr. Aleksey TORGOV, Deputy CEO for Government Relations, BIOCAD
  • Mr. Maksim STETSYUK, First Deputy General Director of LLC «Nanolek»
  • Mr. Andrey KOLESNIKOV, TEVA CEO for GR and Market Access in Russia and Eurasia
  • Ms. Irina YEMCHENKO, Head of GR, Geropharm pharmaceutical company
  • Ms. Victoria GORTINSKAYA, Advisor to the Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade
  • Mr. Sergey Zverev, the Director of the Department for market-access, and external communications of the business unit «Vaccines» of the company MSD
14:00–16:00
PANEL DISCUSSION ON PHARMACOVIGILANCE
ACCREDITED PARTICIPANTS ONLY! Registration is over!
Venue: Tolstoy Hall, 1st floor
Moderator: Mr. Anatoly KRASHENINNIKOV, Director of the National Pharmacovigilance Research Center
Themes*:
  • Key components of the government policy for drug safety
  • Basic recommendations for pharmacovigilance system of drug license holders
  • Main documents processing requirements as outlined in Good Validation Practices
  • Implementation of national standards in preliminary safety analysis reports
Speakers*:
  • Ms. Galina ISHMUKHAMETOVA, Representative of the State Duma of the Russian Federation, State Duma Committee for Health Protection
  • Ms. Valentina KOSENKO, Deputy Head of the Federal Service for Surveillance in Healthcare
  • Mr. Vitaly Polivanov, Head of the Monitoring Center for Effective, Safe and Rational Use of Medicines
  • Ms. Svetlana Setkina, Deputy Head of the Belarus Republic Clinical and Pharmacological Laboratory, WHO expert
  • Ms. Natalya PYATIGORSKAYA, Head of the Department of Industrial Pharmacy of the Sechenov First Moscow State Medical University, Member of the Council for Professional Competence in Pharmacy, Ph.D., Professor
  • Mr. Victor Dmitriev, Director General of the Association of the Russian Pharmaceutical Manufacturers.
  • Mr. A. Skripkin, Head of the Pharmacovigilance Service of Veropharm JSC.
16:00–16:30
Coffee Break
PANEL DISCUSSION
16:30–18:30
MODERN REGULATORY SYSTEM. NEW TRENDS AND INTERACTION MODES
Venue: Big Hall, 2nd floor
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
16:30-18:30
Round table of the council for professional pharmaceutical competences «HR training system for industrial pharmacy»
ACCREDITED PARTICIPANTS ONLY! Registration is over!
Venue: Tolstoy Hall, 1st floor
Moderators: Ms. Elena NEVOLINA, Executive director of the Union «National Pharmaceutical Chamber», Executive secretary of the CPQ; Ms. Mariya LITVINOVA, member of the Council of the Union «National Pharmaceutical Chamber», member of the CPQ
Themes*:
  • Council for Professional Competences: scope of jurisdiction and issues to be solved
  • Qualifications framework in the industry
  • Adopted professional standards for industrial pharmacy. Do they need to be updated?
  • Are specialists with pharmaceutical education demanded in industrial production? Employers' Opinion
  • Low quality of basic education as a probable cause of deviations revealed during pharmaceutical inspections
  • Preparedness of educators to change training programs for pharmaceutical production staff
Speakers*:
  • Ms. Natalya PYATIGORSKAYA, Board Member of the Counsel of Professional Qualifications for Pharmaceutical Industry; Head of the Industrial Pharmacy Chair of the Sechenov First Moscow State Medical University
  • Ms. Liliya TITOVA, CEO of the Union of Professional Pharmaceutical Organizations
  • Ms. Victoria GORTINSKAYA, Advisor to the Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade
  • Mr. Igor NARKEVICH, Rector of the St. Petersburg State Chemical and Pharmaceutical Academy
21:00–23:30
COCKTAIL DINNER
Venue: Big Hall, 2nd floor
August 28, Day Two
INTERNATIONAL DAY
8:30-9:00
Welcome coffee
Venue: Big Hall, 2nd floor
9:00–9:30
OPENING SESSION
Venue: Big Hall, 2nd floor
Moderator: Mr. Dmitry CHAGIN, Chairman of the Board of the EAEU Pharmaceutical Manufacturing Association
Tasks*:
  • Revisiting questions raised during Day 1 of the Conference
  • Day 2 agenda
  • Welcome speech of the coordinator for corporate relations of the International Federation of Students-Pharmacists (IPSF) Martin Koprivnikar Krajnc
PLENARY SESSIONS
9:30–12:00
Issues of effective use of resources and intercountry cooperation in GMP area. Mutual recognition
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»
10:00–12:00
Tatarstan’s pharmaceutical industry attracts investments into the region
ACCREDITED PARTICIPANTS ONLY! Registration is over!
Venue: «Tolstoy» Hall BC «Korston-Kazan»
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)
12:00–12:20
Coffee break
PANEL DISCUSSION
12:20–14:00
New GMP trends in the EEU regulatory system
Venue: Big Hall, 2nd floor
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»
14:00–15:00
Lunch
PANEL DISCUSSION
15:00–16:30
International experience in implementation of labelling of medicines for human use
Venue: Big Hall, 2nd floor
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»
16:30–17:00
Coffee break
PANEL DISCUSSION
17:00–18:30
Overview of GEP trends. ISPE EEU discussion
Venue: Big Hall, 2nd floor
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
18:30–19:00
CLOSING CEREMONY OF THE III ALL-RUSSIAN GMP CONFERENCE
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
August 29, Day Three
BEST PRACTICES` DAY
8:30–9:00
Welcoming coffee
Venue: «Pushkin» Hall, 1 floor
MASTER CLASSES
9:00–11:30
Master class on GMP inspection
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
11:30–12:00
Coffee break
12:00–14:00
Master class: regulation of production radiopharmaceuticals and blood products
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»
14:00–15:00
Lunch
15:00–17:00
Master class on Data Integrity
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
17:00–18:00
Farewell Happy Hour
* – speaker/theme is to be confirmed