Journal of Developing Drugs
Open Access

Accelerating patient access to medicines in Africa

Joint Event on 8^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR & 8^th International Conference and Exhibition on Pharma Audit, GMP, GCP & Quality Control

June 08-09, 2018 | Philadelphia, USA

OumKaltoum Lahlou

University of Barcelona, Spain

Scientific Tracks Abstracts: J Develop Drugs

Abstract :

The role played by properly functioning regulatory systems towards enhancing access to essential medicines for patients is crucial. This is especially the case in Africa which has seen progressive growth in the regulatory environment. At the center of this growth has been the African Medicines Regulatory Harmonization (AMRH) initiative. This initiative seeks to strengthen regulatory capacity and encourage harmonization of regulatory requirements��?with the ultimate aim of expanding access to quality, safe, and effective medicines for patients in need in Africa. A lot of progress has been made during the last years, with initial focus on the East African Community, where harmonization related regulations have already been implemented. The same is now being rolled out in other regions such as West Africa and the Southern African Development Community. Removing bottlenecks and reducing redundancies in regulatory processes that slow access to medicines for patients in need today is critical. In this sense, collaboration between the World Health Organization and relevant stakeholders, including the research-based pharmaceutical industry, on collaborative registration procedures that support fast and efficient review and approval of essential medicines in Africa is essential. African regulatory harmonization offers many benefits to regulatory authorities, patients in Africa and industry alike��?and most critically for the protection of public health. In this regard, it should be noted that the AU, through its technical arm, the New Partnership for Africa��?s Development (NEPAD) Agency has established a medicines regulatory harmonization initiative with the ultimate aim of establishing one central regulatory body in Africa, the African Medicines Agency (AMA).

Biography :

OumKaltoum Lahlou is a Pharmacist and has a Master’s in Compliance in Pharmaceutical Industry from the University of Barcelona, Spain. She is Head of the Regulatory Affairs of North and West Africa region at Merck since 2013. She worked eight years at Bayer in Barcelona then in Casablanca in different positions: Quality Assurance, Industrial Development Department Manager before joining the Regulatory Department. She is a Member of Africa Regulatory Network in IFPMA. She participated as a Writer in the Edition 2016 of the International Pharmaceutical Journal: “Pharmaceuticals Policy and Laws”; Article 7: African Regulatory Harmonization: AMRH Program; “Towards African Regulatory Harmonization Processes–Accelerating patient access to medicines.
Email:kaltoum.lahlou@hotmail.fr