Shingou Sakurai – Contribution of the pharmaceutical industry to the modern development of the state economy. The experience of Japan
Rafael Pérez Cristiá – Approach: The Cuban Regulatory Strategy. Where biopharmaceutical innovation intersects the administration of regulation and control
Goranka Marušić Kontent – Brexit – challenges for all of us
Lesbia Muro – The strategy of sanitary registration in Venezuela depending on the product type and its impact on public health care
Maram Darrag – Specifics of medicines control in Egypt (From regulatory point of view)
A. Ramkishan – Regulatory Tools ensuring transparency of Registration and Inspection Procedures for entering into the Indian Market
Rafael Pérez Cristiá – Export and priority regions. Regulatory and industry tools
Ferenc Lukács – Mutual recognition procedure as a tool to reduce the number of inspections experience of mutual recognition with FDA
Shingo Sakurai – Regulatory tools provided in Japan
Nurlybek Asylbekov – Pharmacovigilance system In kazakhstan
Yuri Olefir – When push comes to shove
Pyatigorskaya Nataliya – Training of Qualified persons of pharmaceutical manufacturers
D.A. Rozhdestvenskiy – Regulation of the drugs circulation in EAEU: what is done and what is up to do
Svetlana Setkina – Legal regulation of pharmacovigilance in EAEU: planned changes, prospects for the development
I.U. Toktonaliev – GMP Legal Framework in Kyrgyzstan
Vitaliy Khilai – How do BIM tools improve quality of PHARMA projects
Oleg Spitskiy – Integration of good engineering practice (GEP) into the pharmaceutical quality system
Jens Peter Gundorf – Validation & Good Engineering Practices in Novo Nordisk A/S
T.M. Vyazmina – Pharmaceutical Quality System in regard to Good Engineering Practice
Christian Wölbeling – From Industrie 4.0 to Pharma 4.0 Operating model and The Holistic ICH Control Strategy
V. Aristov – Pharmaceutical design. Key documents and control points influencing design gmp compliance
A.R. Akhantiev – Production and monitoring of the circulation of labeled drug products – at the final stage of the pilot project
Lev Dumchev – Serialization: is the business ready?
A.R. Akhantiev – Production and monitoring of the circulation of labeled drug products – at the final stage of the pilot project
T.M. Vyazmina – Compliance with Good Practices – Ticket to Company’s Success
Dayana Priscila Paz Donoso – The interrelation of good practices: from development to distribution
Roman Drai – Clinical trials in Russia from GCP harmonization to results acceptance abroad
Romanov Boris, Krasheninnikov Anatoly – Interconnection of good practices: from development to distribution
Valery Makarov – «Blind-spots» of medicine life-cycle from the point of view of the good practices
Ekaterina Nikiforova – Experience in implementing GMP rules in Russia and the history of creating a domestic GMP inspectorate
Jesus Herrera – Good Distribution Practices in the Bolivarian Republic of Venezuela
Narkevich Igor – Standardization and quality control of drugs in Russian Federation: approaches – challenges – solutions – perspectives
Soren Thuesen Pedersen – Staying Ahead of the Curve in an Increasingly Complex Regulatory World as seen from Novo Nordisk A/S, a global pharmaceutical manufacturer
Stephan Roenninger – GMP and Pharmacopoeia: Harmonisation of Basic Regulators’ Tools
D.A. Rozhdestvenskiy – Concept of quality and approaches to its definition at the national level and in the legislation of the eaeu. Drug life cycle management
Suzanne Osbourne – Abnormal toxicity test (ATT) – Drivers for recent changes implemented by WHO, EDQM and other
Thorsten Herkert – GMP Inspection Experience
Ferenc Lukács PhD – Parametric Release Review of the new EU GMP Annex 17 version
Stephan Roenninger – Manufacture of Sterile Medicinal Products: «Annex 1» – DRAFT
Pierre Winnepenninckx – Key theses and regulations of new ICH Q12 Guideline «Lifecycle management»
Nadezhda Arkhipova – Guideline for Elemental Impurities ICH Q3D(R)
Florence Benoit-Guyod – Panel discussion Global trends in the field of GMP topical initiatives, tendencies, best practices EDQM part: trend on GMP deficiencies found during API inspections
N. Popova – Sterilization of medicines, pharmaceutical substances and containers for primary packaging
Marta de Vicente – PIC/S actions for GMP inspection procedures harmonization PIC/S guidance on classification of GMP deficiencies
Ivan Bašic – Data integrity from the inspector’s point of view
E.V. Zelinskaya – Requirements to radiopharmaceuticals circulation and manufacture. Record of introduction of relevant sectoral practices, russia and EAEU
O. Kononov – Experience of JSC «L.Ya. Karpov Institute of Physical Chemistry» in production of radiopharmaceuticals and raw isotopes for the Russian market and cross border sales
A.V. Zverev – Therapeutic radiopharmaceuticals in Russia: state of the industry, main problems and ways to overcome them
Stephan Roenninger – Manufacture of Sterile Medicinal Products: Practical Examples
Henrik Friese – Aseptic handling. Novo Nordisk A/S
Henrik Friese – Automatisation and robotics in aseptic handling
Vincent Neuviale – GMP inspection for VMP by anses-anmv
Steven A. Karli – Inspection of Veterinary Biologics in the United States An Overview
Chantal Cazeault – Panel discussion GMP inspection process – Health Canada
Nikita Novikov – Process validation – actual regulation, performing and inspection
I.V. Nikitina – GMP requirements for api manufacture. Sterility
Maklakova Olga – Re-inspection of production sites: preparation of CAPA plans and their implementation
Vitaliy Kazulkin – A risk-based approach to the classification of detected non-conformities with GMP requirements. Regulatory trends and case studies
Julia Grishina – Re-inspection of production sites: preparation of CAPA and their implementation
Achiraya Praisuwan – Strategies for preparing an effective CAPA plans
Olga Eichler – An integrated approach to the creation of an effective human plasma harvesting system for fractionation
Evgeny Shepodko – Aspects of PPP according to the program of modernization for regional blood transfusion stations under SPIC
Aleksandr Khokhriakov – Practical aspects Of human plasma for fractionation manufacturing. Process approach
Tyurikov Yuri – Problems production blood product
A.L. Poptsov – Analytical control system as a measure to ensure infectious safety of human plasma for fractionation
Elena Petrova – Plasma collection and processing system in Italy
Sergey Goryunov – Plasma fractionation market, regulatory issues, existing problems and ways of their solution
Pyatigorskaya Nataliya – Qualified persons – transition to new requirements and certification
N.V. Putilo – Legal issues of pharmaceutical inspectorate organization in Russia and EAEU: challenges and possible solutions
Alexander V. Prepyalov – Legal implications of failure to confirm the compliance with GMP guidelines for subjects of drug circulation
Anastasia Kalmykova – «Regulatory guillotine» in the pharmaceutical industry: general approaches and implementation specifics
Pavel Kabytov – Administrative enforcement actions in case of incompliance with GMP
Pavel Sukholinsky – How to Protect Rights When Generics Are Registered?
Volovich Natalia – Compliance with the requirements of the registration dossier as one of the key aspects of the assessment during GMP inspections
T.M. Vyazmina – Toxicology for pharmaceutical production as seen by a non-toxicologist
Vyacheslav Goryachkin – GMP requirements for the production of api (overview of GMP part II)
Maram Darrag – How to prevent cross contamination
Egor Rybakov – Current regulatory requirements for the prevention of cross-contamination in pharmaceutical manufacturing. The «expectations» of inspectors and the practice of inspection
Vladimir Smirnov – Compliance with the requirements of the registration dossier as one of the key aspects of the assessment during GMP inspections
