III Всероссийская GMP-конференция | Conference matherials
Conference matherials
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Results 2018
III GMP Conference 2018 Summary
August 27, Day One
REGULATORS` DAY
11:15–12:45
Drivers of pharmaceutical market growth. Global perspective
K. VOLOKNITSKAYA – Tools for development of pharmaceutical production in the city of Moscow
14:00–16:00
Pharmaceutical industry of the Future. Government and business perspectives
Igor NARKEVICH – Education for Innovative Economy: Ways for Development Victoria GORTINSKAYA – GMP: Strategic aspects Aleksey TORGOV – Export potential of the Russian pharmaceutical industry Dr. Matthias WERNICKLE – Contract Manufacturing in Russia: Merck Experience Roza YAGUDINA – MarketAccessin the context of industry and the state. Points of intersection and contradictions Ilshat GAFUROV – Problems, tasks and approaches in the field of drug design and development Vadim KUKAVA – Proposals of Association InPharma for the «Pharma 2030» Strategy
16:30–18:30
MODERN REGULATORY SYSTEM. NEW TRENDS AND INTERACTION MODES
Valentina KOSENKO – Modern regulatory system. New trends, interaction formats Paul STOTT – Transformation of the regulatory paradigm for medicine quality: from the concept of normative document to the Quality by Design approach Elena POPOVA – Regulatory systems convergence: current trends, challenges and opportunities Dr. S. AUSBORN, F. HOFFMANN – Accelerated Development Programs for Innovative Therapies: Opportunities for Patients and Technical Challenges Pär TELLNER – Trends in the development of regulatory systems by the example of ICH countries
August 28, Day Two
INTERNATIONAL DAY
9:30–12:00
Issues of effective use of resources and intercountry cooperation in GMP area. Mutual recognition
Valentina KOSENKO – Issues of effective use of resources and intercountry cooperation in GMP area. Mutual recognition Roberto CONOCCHIA – EMA role in GMP Manufacturing and Quality Compliance Stephan RÖNNINGER – Regulatory Convergence in GMP and Inspection Practices: Benefits for regulators, industry and patients Andrew CHANG – Authority Inspections: Preparing, Conflicts and Mutual Recognition Mohan GANAPATHY – Impact of Global Regulatory Approaches on Compliance and Development of pharmaceutical products Ulrich BECHT – Bridging GMP regulations in different countries – A company’s approach Anna ARUTYUNOVA – Quality Policy: a formal approach or a Company strategic objective? Elena POPOVA – Regulatory systems convergence: current trends, challenges and opportunities Elena POPOVA – Preparation to EAEU GMP-inspections. Industry view Shingou SAKURAI – Efforts of International cooperation of Japan in GMP area
12:20–14:00
New GMP trends in the EEU regulatory system
Yelena STEPKINA – Republic of Kazakhstan: GDP-inspections experience Chinara MAMBETALIEVA – Legislative basis of the pharmaceutical inspectorate forming in the Republic of Kyrgystan Natalia PYATIGORSKAYA – Certification of qualified persons for pharmaceutical production – conditions and requirements of the Eurasian Economic Union
15:00–16:30
International experience in implementation of labelling of medicines for human use
Álvaro Israel Pérez VEGA – Labeling of medicines Domenico di GIORGIO – Regulators View on Status of Mass Serialisation Implementation and Anti-Counterfeiting D. BAGLEY – Track & Trace key differences in Russia Evgeny BELOV – About implementation of Track & Trace at manufacturers Andrey AKHANTYEV – Pharmaceutical manufacturer’s experience in introduction of a labeling system and monitoring of distribution Джозеф Трапл – Безопасная доставка лекарственных препаратовРазумность. «Планирование – Внедрение – Функционирование»
17:00–18:30
Overview of GEP trends. ISPE EEU discussion
Louis TURCOTT – Intelligent supply chaintm (ISC) Josef KRIEGL – Articulation of Pharma 4.0 concept. Trends` review Zdenek PAVELEK – Assessment of the transfer of technology and analytical techniques Dmitriy POLSTYANOV – The Fourth Industrial Revolution (PHARMA 4.0) ZIV DEE NOOR – Modern Manufacturing of Active Pharmaceutical Substances Sergey MOVSESOV – Issues of technical regulation and standardization of manuals and rules for the design Achim LUCKEL – Technology Transfer – From Development to Production
August 29, Day Three
BEST PRACTICES` DAY
9:00–11:30
Master class on GMP inspection
Ivan GULYAEV – CAPA documents and follow-up GMP-inspection Agnes SZABO – Common Aim of Supervisory Authorities Luba SKIBO – Russian GMP Inspections of Foreign Manufacturers Independent Point of View Kris EVANS – Insights from a Former FDA Representative Yuliya GRISHINA – Requirements for sponsor of clinical trials Yuliya GRISHINA – Competences required of inspectors Inspectors’ rules of conduct Najib SEHAT – Audit MANAGEMENT In a GMP ENVIRONMENT Olga MAKLAKOVA – Waiting for Eurasian Union GMPinspection. Gap-analysis from the point of view of the Russian manufacturer Evgeny RYBAKOV – Course of Actions of a pharmaceutical manufacturer in the event of the production site renaming Evgeny RYBAKOV – Classification of Deviations Evgeny RYBAKOV – Organization and certification requirements for clean rooms Evgeny RYBAKOV – Regulatory and legal grounds for inspecting foreign manufacturers
12:00–14:00
Master class: regulation of production radiopharmaceuticals and blood products
Franz SCHONFELD – Licensing of nuclear medicine sites International practice Alexey MARTYNOV – Biomedical cell products – is a new trend in pharmaceutical industry Vera BOGDANOVA – Regulation aspects of plasma supply for production of medicinal product – plasma derivatives Issues of quality assurance Elena ZELINSKAYA – Production of APIs for radiopharmaceuticals Elena ZELINSKAYA – Metrology system in pharmaceutical production Poverka-calibration of measuring devices
15:00–17:00
Master class on Data Integrity
Anton WILLI – Novartis Data Integrity Gilda D'INCERTI – Data Integrity Governance: milestones in the global arena Gilda D'INCERTI – Data Integrity & Computer Systems Guidance Validation Roberto BERTINI – A practical approach to Data Integrity Assessment and CAPA Plan