Ensuring Drug Security Forum

Regulation 2.0: Stress Test of the System from the Pandemic to New Challenges

15 Jun , 10:00–11:30
‘Ensuring Drug Security’ Russian Pharmaceutical Forum
Pavilion G, conference hall G6

The drug circulation regulatory system faced new, unprecedented challenges in 2022, such as the risk of a significant increase in the cost of medicines and the protection of the national market against shortages of vital drugs both due to the curtailed supply of original imported drugs as well as logistics disruptions in the supply of raw pharmaceutical materials. The experience Russia has gained from the COVID-19 pandemic has strengthened its regulatory system and prompted the government to make quick and effective decisions that have proven that the development, registration, and commercial release of drugs can be significantly accelerated without compromising safety and quality. This experience should be adopted today and continued. How are shortages of raw pharmaceutical materials and logistics problems affecting the cost of finished products? What government measures to regulate and control costs can protect the interests of pharmaceutical manufacturers, pharmacy chains, and end consumers? Is the model of state procurements for the production of vital and essential drugs and new dosage forms with the guaranteed procurement of drugs for several years applicable in the current realities that Russia is facing? Will the compulsory licensing system be able to insure the Russian market in the event the supply of imported drugs decreases or their prices significantly increase? How might potential measures to speed up the registration process affect the quality of products? What is the best way to maintain effective control and oversight activities and ensure the quality of medicines in the face of the new challenges? What is the social significance of pharmacovigilance?

Alla Samoylova, Head, Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Sergey Glagolev, Deputy Minister of Health of the Russian Federation
Dmitry Zemskov, Executive Director, Biochemist
Irina Maysak, Deputy Director, State Pharmaceutical Supervision in the Sphere of Circulation of Medicines "Gospharmnadzor" (online)
Chinara Mambetaliyeva, Deputy Director, Department of Technical Regulation and Accreditation, Eurasian Economic Commission
Timofey Nizhegorodtsev, Deputy Head, Federal Antimonopoly Service of the Russian Federation
Vitaliy Omelyanovskiy, General Director, Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Aleksandr Petrov, Chairman of the Subcommittee on Medicines, Development of the Pharmaceutical and Medical Industry of the State Duma of the Federal Assembly of the Russian Federation for Health Protection

Front row participant
Dmitry Sychev, Rector, Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation