PPT-ECBS: Vaccines and Biotherapeutic products

Dr Ivana Knezevic TSNEMPHIS WHO Geneva 5 th November 2014 EMP Technical Briefing Seminar Outline Norms and standards for biologicals in the context of WHO Strategic drivers and issues. Vaccines greatly reduce the risk of infection by working with the bodys natural defenses to safely develop immunity to disease This fact sheet explains how the body fights infection and how vaccines work to protect people by producing immunity The I Science, Technology, and Global Health. The Need for New Products. Characteristics of new technologies must reflect the following: . Most important target groups are poor people . Quality of care and injection safety is often low. 1 1 on Similar Biotherapeutic Products – Biosimilars Similar Biotherapeutic Products – Biosimilars Innovative biotherapeutic products (e.g. proteins, monoclonal antibodies) are losing Vaccines. North Carolina is an innovative leader in vaccine research, development . and manufacturing.. vaccines actually are one of the safest and most . cost-effective. They have prevented millions of deaths and . Update July – Dec. 2015. IPC Meeting, WHO HQ, Geneva December 10-11, 2015 . Kees de Joncheere. EML 2015: Full report available. 586 pages, 1082 references. http. ://apps.who.int/iris/bitstream/10665/189763/1/9789241209946_eng.pdf?ua=1. ECBS: Vaccines and Biotherapeutic products Dr Ivana Knezevic TSN/EMP/HIS WHO, Geneva, 5 th November 2014 EMP Technical Briefing Seminar Outline Norms and standards for biologicals in the context of WHO ENGLISH ONLYEXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATIONGeneva 17to 21October 2016Human Challenge Trialsfor Vaccine Developmentregulatoryconsiderations World Health Organization 2016All rights reser What is so special about how they are made? How to dierentiate them? A medicine which has been licensed by the national regulatory authorities on the basis of a full registration dossier; i.e. th 1 To understand how vaccines work and the foundation of recommendations for their use, it is helpful to understand the basic function of the human immune system. The following description is simplifie Implementation . of . WHO standards for regulatory evaluation of similar b. iotherapeutic . p. roducts SBPs. Ottawa. , . 6. th. . September. . 20. 13. . Dr . Ivana Knezevic, WHO/HIS/EMP. Outline. . great promise, and several types are being tested in. Humans. • DNA vaccines take immunization to . a new. technological. level. • . These vaccines dispense with both the whole . organism and . V6.08.11.2022. Afrigen. South African hub. +. Biovac. Institute Pasteur Tunis - . Tunisia. BioGeneric. Pharma –. . Egypt. TBD - . Kenya. Institute Pasteur Dakar - . Senegal. Biovaccines. -. Nigeria. Antigens . Adjuvants . Keep vaccines safe and long lasting. Preservatives . Stabilizers. Used during the production of vaccines. Cell culture materials. Inactivating ingredients. Antibiotics. VACCINE COMPONENTS. What is ECB?. ECBs are commercial loans. Raised by eligible borrowers. From non-resident entities. For permitted end use prescribed by RBI. Should conform to parameters directed by RBI. Borrowing . vs.