Full course description
This is an evolving regulatory requirement in which the Life Science industry has struggled to maintain compliance; because of its complexities, outsourcing has increased. The skill sets required to learn and excel in disclosures are the focus of this program. This course will provide hands-on experience with writing and reporting to global registries with an emphasis on Clinicaltrials.gov (US) and EudraCT (EMA). Students will learn about the legal and ethical basis for disclosure of the clinical trial protocol and results, beginning with a comprehensive overview of Clinicialtrials.gov and EudraCT. The course will define how to meet the technical requirements of the registries, to effectively summarize protocols and results. Other mandatory international registries will also be reviewed, and workflow processes and systems for operationalizing clinical trial disclosures will be demonstrated. This is an ideal course for the detail oriented, regulatory-focused, compliance-minded scientist or aspirant within the pharmaceutical industry.