National Medicines
Conference
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  • Home
  • Past editions
    • 2018 edition
      • Agenda
      • Speakers
      • Institutional Partners
  • Contact
  • roRomână

Agenda

Day 1 - Conference
20.09.2018
09:00 — 09:30
Registration of the participants
09:30— 10:15
The official opening of the National Medicines Conference
10:15 — 11:00
The medicine - regulatory issues

1. Regulatory framework. From legislation to practice
2. Medicine field objectives in the context of taking over the Presidency of the Council of Europe
3. Strengthen the administrative capacity of national authorities regarding medicines regulatory mechanism

11:00 — 11:20
Coffee break
12:20 — 12:50
Pharmacovigilance and medicine safety

1. The importance and the role of pharmacovigilance activity in medical and pharmaceutical practice. Identifying and managing the risks associated with the use of medicines – practical aspects
2. Pharmacovigilance in elderly population
3. Pharmacovigilance – biological, biosimilar therapies

12:50 — 14:00
Vaccine Safety - regulatory issues and practical issues

1. Vaccine Safety Profile – establishment and monitoring
2. The role of OMCL in ensuring the quality and safety of vaccines

14:00 — 15:00
Lunch break

15:00 — 16:10
Evolution of the regulatory framework in clinical trials
16:10 — 16:30
Coffee break
16:30 — 17:30
The role of communication in patient safety

1. Pharmacovigilance: the identification and the reporting of adverse reactions
2. Communication of safety aspects of medicines
3. Pharmacovigilance from patient perspective

17:00 — 18:00
The evolution of the regulatory framework in the field of clinical studies
Day 2 - Conference
21.09.2018
10:00 — 12:00
Medication availability and patient access to therapies

Round table
1. Causes of medicine discontinuities. Other ways for patients to access the medicines
2. Authorization for special needs and parallel import
3. Provide the access of patients to special pathology treatments

12:00 — 12:20
Coffee break
12:20 — 13:20
Off-label use and medication errors

1. Off-label use
2. Medication errors and malpractice

13:20 — 14:20
Lunch break
14:20 — 16:00
The aspects of fundamental research and innovation in the field of medicine

1. Research institutes – infrastructure and interdisciplinary collaborations are an absolute necessity in development
2. In MS Research, it might take an industry
3. Benefits of strengthening the collaboration between UMF “Carol Davila” – NAMMD
4. Cytotoxicity and cellular action of the drug assessed by in vitro methods and techniques
5. Safety and efficacy of the in vivo animal product evaluated

16:00 — 17:00
Importance of GMP and GDP in drug safety. Counterfeiting and Illegal Trafficking in Drugs vs. patient safety - Stage of FMD implementation
17:00 — 18:00
Communication to the general public

1. Ethics in advertising on medicines
2. The importance of accurate patient information on medicinal products and adherence to treatment

EVENT MANAGEMENT