2019 Round Table
Regulation of Biodrugs: interchangeability, substitution & switch
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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