A guide to an effective clinical trial protocol in cGMP and cGCP | 2470
Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

+44 1478 350008

A guide to an effective clinical trial protocol in cGMP & cGCP as a tool for sustenance of ethical principles and regulatory requirements in the pharmaceutical and research industry

3rd International Summit on GMP, GCP & Quality Control

September 25-26, 2014 Valencia Convention Centre, Spain

Peter Odeh and Helen Odeh

Accepted Abstracts: J Dev Drugs

Abstract :

The Clinical Trial Protocol is the foundation upon which the study design is built. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary goal of a trial is to generate new knowledge about a potential medicine so that regulatory authorities can determine whether the medicine is safe and effective and the primary purpose of clinical trial is to advance the knowledge of researchers and regulators so that new treatments and cures can be developed. A guide to an effective Clinical Trial Protocol in CGMP & CGCP as a tool for sustenance of Ethical Principles and Regulatory requirements in the Pharmaceutical and Research Industry is a contemporary perspective on how professionals in the medical, pharmaceutical and research industries can utilize available resources in developing their clinical trial protocol based on sound scientific and ethical doctrines or principles with the primary intention of protecting research subjects or participants while adding meaning to the necessity for the continuation of research practices in our society. Additionally, a well articulated clinical trial protocol and subsequent amendment(s) in practice, as the case may be, will further enhance professionals? understanding and limitation(s) with greater emphasis on risk management, continuation of the study and importantly when to stop if it is deemed necessary or if the risk/benefit ratio becomes high enough to compromise either the study participants and or compromise ethical principles as enunciated in the Declaration of Helsinki, the Belmont report and the GCP principles contained in the International conference on harmonization (ICH).

Biography :

Peter Odeh is a Research Medical Laboratory Scientist/ Medical Technologist and Clinical Laboratory Scientist with SNBL Clinical Pharmacology Center in Baltimore Maryland. In the year 2002, Odeh received the International Travel Grant Award and the Gallwas Membership Grant Award of the American Association for Clinical Chemistry in Orlando Florida during the AACC scientific meeting. In addition he received several other awards such as the McAuley Silver Award for outstanding leadership and quality of work at Mercy Medical Center in Baltimore and Continuing Education Certificate of Excellence by the American Medical Technologists Institute for Education. He has vast experience in working both in the hospital and research environment, has written series of articles and is the oversea consult director of technical services for ROPAN DIAGNOSTIC (NIG) LTD.