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
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
1. Vaccine Safety Profile – establishment and monitoring
2. The role of OMCL in ensuring the quality and safety of vaccines
1. Pharmacovigilance: the identification and the reporting of adverse reactions
2. Communication of safety aspects of medicines
3. Pharmacovigilance from patient perspective
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
1. Off-label use
2. Medication errors and malpractice
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