Highlights: A scientifically-developed well-written clinical study protocol is vital for the smooth conduct of a clinical study. A clinical study that successfully ensures patient safety and evaluates drug efficacy is dependent on having a high-quality clinical study protocol, compliant with various regulatory guidelines. A well-developed clinical study protocol facilitates a smooth approval process by regulatory agencies, leading to a timely study start and conduct, and enabling the investigational medical product to swiftly reach the patients. The clinical study protocol development follows a collaborative process involving various contributing functions, highlighting the importance of team efforts and stakeholder management in developing this document.
The aim of this workshop is to train participants on the various aspects of protocol development for interventional global clinical trials. The intended audience include Medical Writers who are new or have minimal protocol writing experience, as well as any other participants that are involved or interested in the development of this regulatory document. At the end of the workshop the participants should have the skills to plan and develop a clinical study protocol.
Who should attend: Regulatory Medical Writers, Clinicians, Trial managers, and anyone who is involved in writing clinical study protocols. This workshop is also open to Publication Writers, Scientific Writers, Regulatory Affairs Specialists, Clinical Trial Investigators, Research Scholars, Scientists, and Health Care Professionals from Pharmaceutical Industry, Contract Research Organizations, Government Agencies, Non-profit Organizations/Associations, and Academia, Medical, Pharmacy or Life-science students or Professionals interested in making a career in Clinical Research.