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
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
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
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
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»
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
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
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
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
