Clinical trial Evaluation

Clinical trial is one of the fundamental steps in the marketing authorization of any product. The regulation of clinical trials aims to ensure the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible. In addition, the organization plays a key role in ensuring that the standards of good clinical practice (GCP) are applied.

The National Organization of Research and Control Of Biological Products relies on the results of preclinical and clinical trials carried out by pharmaceutical companies to reach its opinions on the authorization of medicines.

The regulatory oversight of clinical trials for biologicals is implemented by the Clinical Trials Evaluation department at NORCB on basis of presidential decrees no. (398/1995, 244/2009), ministerial decrees no. (95/2005, 436/2006, 297/2009, 399/2010, 150/2015, 820/2016), national and international guidelines ( ICH, WHO, and others…etc.).

Our Creative Team

Dr. Heba Khalil

Department Manager

Ph. Ola Abdel Ghany

Department Deputy and safety monitor &evaluator

Ph. Aya El- Abd

Department Quality Manager

Ph. Raneem Kotb

Staff Member

Ph. Amr Ali

Staff Member

Ph. ٍMostafa Faisl

Staff Member

Ph. Omnia Ayman

Staff Member

Ph. Lobna Gameel

Staff Member

Ph. Rania Shosha

Staff Member

Ph. Salma Salah

Staff Member

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