Training of Qualified persons of pharmaceutical manufacturers

1. Training of Qualifiedpersons of pharmaceutical manufacturers PyatigorskayaNataliyaValeryevna Head of Department of Industrial Pharmacy SechenovUniversity Doctor of pharmaceutical sciences, Professor

2. Requirementsstated in EEC Council Decision No. 73 “On the certification procedure of Qualified persons of pharmaceutical manufacturers” • applied (medical and biological) physics; • general and inorganic chemistry; • organic chemistry; • analytical chemistry; • pharmaceutical chemistry (including drug analysis); • biological chemistry; • physiology; • microbiology; • pharmacology; • pharmaceutical technology; • toxicology; • pharmacognosy.

3. Training program "Industrial Pharmacy" approved by Order of the Ministry of Education and Science of Russia on December 1, 2016

4. Master's program «Industrial pharmacy» Entrance examination: • General and inorganic chemistry • Organic chemistry • Analytical chemistry • Basics of biology • Basics of pharmaceutical management Enrollment: • 2018 - 30 people • 2019 - 43 people

5. General professional competences • conducting and organizing research in the field of drug circulation; • analysis, systematization and presentation of research data; • application of innovative process management methods; • determination of methods and tools for quality assurance used in the field of drug circulation taking into account the life cycle of the drug; • organization, management and administration of production, regulatory or research departments in accordance with established requirements and best practices; • organization of interaction between drug manufacturers, research organizations with regulatory bodies that exercise powers in the field of drug circulation.

6. Professional competence Able to manage the work of the pharmaceutical quality system (PQS) for the production of medicines Progress indicators: • Plans and evaluates PQS • Plans and analyzes the basic elements and processes of PQS and GMP • Applies theoretical fundamental knowledge in the field of chemistry, biochemistry, physiology, physics, pharmacology, microbiology, toxicology and pharmaceutical sciences to analyze and solve practical pharmaceutical problems in drug quality assurance • Plans and evaluates the results of quality audits (self-inspections) of pharmaceutical production, contract manufacturers, suppliers of raw materials • Analyzes and evaluates the conformity of the basic production processes and methods of drug control to the established requirements and the current level of development of pharmaceutical sciences • Applies modern communication technologies in professional activities • Maintains qualifications at modern level in the light of the achievements of scientific and technological progress

7. Scope of education “Quality Assurance of Medicines (Qualified Person)” • Design, statistics and ethics of pharmaceutical research and drug lifecycle management • Leadership, Project and Innovation Management • Medical Physics, Physiology, Biochemistry • General and clinical pharmacology • Toxicology and preclinical development of drugs • Information Technology • Pharmacognosy • Microbiology and Pharmaceutical Microbiology • Pharmaceutical Chemistry and Pharmacopoeia Analysis • Pharmaceutical Technology and Packaging • Pharmaceutical Development • Good practices and industrial quality management systems • Regulatory science • Good Manufacturing Practice (GMP) • Pharmacovigilance Practice • Organizational and management practice • Research work

9. THANKS FOR ATTENTION! www.gmp-mma.ru e-mail: osipova-mma@list.ru Tel. +7 (499) 128 57 55