Samer Najjar

Owner
Pharmaceutical Management
Sana Pharma
Jordan

Business Expert Cardiology
Biography

"General Manager for Sana pharmaceutical research company. • Member of JFDA committee for sites inspection and approval • Member of JFDA committee for Quality control on pharmaceutical industry. M.Sc. Pharmaceutical technology, with focused research on transdermal drug delivery system and drug release from creams and patches. 16 years of experience in pharmaceutical research. Extensive knowledge and experience of analytical methods development, validation, Preformulation, stability testing, and scaling up of products. Extensive knowledge and experience of regulatory filing including CTD dossiers preparation and response to regulatory inquiries. Good knowledge of IPR issues related to formulation and registration processes. Extensive knowledge of pharmacokinetics related to drug development and conduction of bioequivalence studies, with solid experience in monitoring and auditing of bioequivalence studies and CRO's. Good knowledge and experience in cGMP and site inspection. Active in many pharmaceutical research areas with more than 8 published articles and some others under publications. Basic achievements: • Establishment of Sana pharmaceutical research company, Amman-Jordan, in 2007, as a market driven Research Company with effective networking capabilities. The company has been recognized as the outsourcing partner for many pharmaceutical companies in the region. • Establishment of interactive research area with academic institutes."

Research Intrest

 Pharmaceutical Research, Oursourcing