Master Class. Part 1 (Theory)

10:00 — 12:30

Main hall

MASTER CLASS. PART 1 (THEORY)

Most Frequent Non-Conformities. Experience of Pharmaceutical Inspectorates of Various Countries

Questions and topics for discussion:

  • Typical non-conformities of the pharmaceutical inspections of the member states of the Eurasian Economic Union
  • Experience of other countries’ pharmaceutical inspectorates

MODERATORS

Madina Sottaeva 

Head of Pharmaceutical Manufacturing Production Inspection Department of the Federal State Institution «SID and GP» under the Ministry of Industry and Trade of the Russian Federation

SPEAKERS

Mkrtich Shakaryan

Head of the Department of Good Pharmaceutical Practice, CJSC “Scientific Center for Expertise of Drugs and Medical Technologies named of Academician Emil Gabrielyan”

Alena Launik 

Head of the Department of Pharmaceutical Inspection of the Main Department for Control of Medical Activities and Circulation of Medicines of the Ministry of Health of the Republic of Belarus

Farida Makeyeva

Head of the Inspection Department of the National Center for the Examination of Medicines and Medical Devices of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan

Chynarkul Kulova

Chief Specialist of the Good Pharmaceutical Practices Division, Department of Pharmaceuticals and Medical Devices Supply, Ministry of Health of the Kyrgyz Republic

Nadezhda Arkhipova

Deputy Head of the Directorate for Inspection of Medicines Manufacturers, Federal State Institution “SID and GP”, Ministry of Industry and Trade of the Russian Federation

Jesus Herrera 

Head of Directorate for Medicinal Products and Cosmetics, Autonomous Health Control Service, Bolivarian Republic of Venezuela

Nani Handyani

Head of Quality Management System Team, Directorate for Drug, Narcotics, Psychotropics, an Precursor Production Control, Indonesian Food and Drug Authority

Fatemeh Bashokouh

Head of the Inspection Office, Iran Food and Drug Administration (IFDA)

Carolyn P. Custodio

Food-Drug Regulation Officer V, Field Regulatory Operations Office, Food and Drug Administration Department of the Philippines

Tanya Zenaida Oviedo Latorre

Specialist in Quality Management of Pharmaceutical Products – GMP Inspector, Directorate General of Medicines, Supplies and Drugs (DIGEMID), Peru

Milton Eduardo Zambrano Masache

General Technical Coordinator for Certification, National Agency for Regulation, Control and Sanitary Surveillance (ARCSA), Ecuador

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