(NAR) VOL. 12 NO. 1 / JANUARY - MARCH 2001
a. Must be a Doctor of Medicine duly registered with the Professional Regulation Commission5. Duties and responsibilities of the Medical Director:
b. Finished a residency training program in a reputable medical facility or is a faculty member in a recognized medical school, preferably in Pharmacology for at least three (3) years or any equivalent training in the field of Pharmacoloy or Clinical Pharmacology
c. Must have satisfactorily earned the Diploma in Pharmaceutical Medicine or passed the examinations given by the Specialty Board of Pharmaceutical Medicines within three (3) years of being employed by any pharmaceutical company in the Philippines.
1. Clearance of all communications with the Bureau of Food and Drugs regarding New Drugs and Investigational New Drugs including follow-up of application for registration of New Drugs, Investigational New Drugs and matters arising from clinical investigation must be coursed through the Medical Director with the assistance of the registered pharmacist of the establishment.This Order supersedes Administrative Order No. 34, series 1979 and all other orders inconsistent with this Order.
2. Approval of all package inserts, labels, brochures and other labeling and promotion materials.
1 and 2 shall be undertaken with the assistance of the registered pharmacist of the establishment prior to submission to the Bureau of Food and Drugs.
3. Serve as liaison officer with the BFAD, Pharmaceutical and Health Care Association of the Philippines and other equivalent pharmaceutical industry associations, the Philippine Medical Association and its specialty and affiliate societies as well as other government agencies and related organizations;
4. Implementation of the following clinical trial activities:i. Prepare or adopt clinical trial protocols for pre-and post-marketing phases of drug development;5. Assistance in the training program of medical representatives, supervisors, pharmacist and other personnel of the drug establishment.
ii. Coordinate the conduct of clinical trials with the clinical investigator(s) and clinical research associates;
iii. Submits a complete report on the outcome of a clinical trial to the BFAD.