컨설팅내용
Project Management
As Global Project Director led teams to develop and obtain marketing approval in parallel in Europe and America involves trouble shooting, contingency planning and coordination of and communication with team members, investígalo rs, reguiatory authorities and sponsor company. Knowledge in all aspects of Drug Development.
Reguiatory
Researched fast track and Orphan drug strategies and applied for and received special designations from FDA and EMEA under which the drugs were approved, resulting in shorter timelines and reduced fees (saving money and time). Developed good working relationships with reguiatory authorities. Have filed 505 (b)(l), 505 (b)(2)applications withsuccess.
Clínica! Triáis
Determine the best strategy for conduct of clinical studies wíth a balance between speed and costof studies in different countries. Also the regulatory differencés in obtaining clinical trial a p pro vals are.taken into consideraron. Havedeveloped a large network of Investigators, especially in oncology.