2019 Round Table
Regulation of Biodrugs: interchangeability, substitution & switch
Importance of control and management of the complexity of Biosimilars. It is the tole of the authorities to study the concept of interchangeability and decide on these following comparability studies
- Comparability is demonstrated with quality and bioequivalence studies
- Question of the comparator element during comparability tests
- What are the best studies for
demonstrate comparability?
The decision-maker (authorities) must position himself on the question of interchangeability and the payer on the question of switch / substitution
- Importance of also implementing the tools to implement the strategy in the market, that the strategy be applicable
Audience
- Department of Health and Hospital Reform, Ministry of Health of Algeria, Dr. Yagoub
- Managers of MOH Affiliated Institutions, ANPP – National Agency of Pharmaceutical Products, Dr. Achouak Ghorab
- Pharmacovigilance Center Prof. Nadjat Loumi
- Toxicology Center, Prof. Fatma Zoha Hadjadj Aoul
- Ministry of Industry
- The National Council of the Order of Pharmacists
- The National Union of Community Pharmacists
- Practicioners
- Senior managers of companies & representatives of the health sector
Attending Experts
Dr. Yagoub Ghania
Ministry of Health, Population & Hospital Reform Algeria
Dr. Achouak Ghorab
National Agency of Pharamceutical Products
Dr. Michael Muenzberg
Dr. Valderilio Azevedo
EDUMED
Dr. S. Harinarayana Rao
Reliance Life Sciences
Pr. Ahlam Abdelaziz
JFDA
