Organizing Committee
Biography
Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Medicines He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, Other ICH Guidelines and now in the US-FDA Biosimilars Guidelines. He is a Chartered Expert in Pharmacology -Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organizations. Dr Mikhail is member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany. and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia
Research Interest
Dr. Michel Mikhail’s area of expertise is Non-Clinical Pharmacology and Toxicology as well as Global regulatory Affairs and Regulatory Agencies Interaction. In particular interaction with the US-FDA, the EU_EMA as well as National Agencies in Europe such as UK-MHRA, German BfArM and PEI, France’s ANSM, Sweden’s MPA, among others, interaction with Japan’s PMDA and Emerging markets Agencies. Dr. Michel Mikhail is an Expert in Biosimilars. He is Interested in Immuno-Oncology, Regenerative Medicine, in vitro and in vivo Animal modeling, and mechanisms of Action associated with diseases and regenerative medicine.
Biography
DR. Rula M. Darwish is currently working as a professor and as Dean for the faculty of pharmacy at University of Jordan. She worked as Chairman for the Department of Pharmaceutics and pharmaceutical technology, University of Jordan (2003-5 & 2012-13). She attended various conferences and published many articles in international journals.
Research Interest
DR. Rula M. Darwish research is mainly focused on Antibiotics and the effects of formulation ingredients on antimicrobial activity, Antimicrobial effects (including antifungal, nematicidal etc.) of different plant extracts, The preserving effect of different formulations, Invertebrate pathology, Parasitology, Microbial Resistance and how to improve the effects of antimicrobial agents on resistant strains of microorganisms, Control of cross infections, Disinfection and Sterilization, Nematicidal effects of natural products, Investigation of new anticancer drugs from medicinal local plants, Discovery of new insecticidal natural products from local plants.
Biography
Dr. Mostafa Norizadeh Tazehkand from Iran (Mioandoab-Qushachay) is currently working as an Assistant Professor in Pharmaceutical Biotechnology department, Bulent Ecevit University, Zonguldak, Turkey. He completed his B.Sc. in Molecular and Cell Biology at Tonekabon University, Iran. Later in 2012, he graduated with M.Sc. in Biotechnology at Cukurova University, Turkey. Dr. Mostafa did his PhD. in Biotechnology at Cukurova University, Turkey in the year 2016. He has published several papers (More than 30) in reputed journals and has participated in several international conferences. He is working as an editorial member in almost 25 scientific journals. His research interests include Vaccine production, Recombinant protein production, Study of cancer, Study of gene expression, Cloning, Study of chromosomal and genetic abnormalities.
Research Interest
Dr. Mostafa Norizadeh Tazehkand's research interests include Vaccine production, Recombinant protein production, Study of cancer, Study of gene expression, Study of chromosomal and genetic abnormalities.