Startdate:
8 May 2012 - 10 May 2012 Location:
Medicademy
Lersø Parkallé 101
2100 København Ø
Purpose:AIM: BY THE END OF THIS MODULE, THE STUDENT SHOULD BE ABLE TO:
Understand the pre-clinical and clinical aspects of pharmacovigilance, including pre-clinical safety studies and safe dose selection for first human trial, decisions for safety margin and first-dose-in-man, principles of safety in phase I, II and III studies, reproductive toxicology, and regulations for safety assessments, etc. Analyse principles of safety in phase I, II and III studies, etc. Use principles of safety in phase I, II and III studies, and understand safety monitoring from an authority perspective. Content:CONTENTS
Pre-Clinical Safety Studies Pre-Clinical Safety Studies and Safe Dose Selection for First Human Trial Phase I Study - What Do We Need? Decisions for First-in-Man Decisions for Safety Margin and First-Dose-in-Man Regulatory Requirements: Pre-Clinical and Phase I Pre-Clinical ADME, PK and Antigenicity Reproductive Toxicology Principles of Safety in Phase II Studies Regulatory Requirements: DMC II/III and Adjudication Principles of Safety in Phase III Studies New Horizons in Safety Sciences Mutagenicity and Carcenogenicity Regulations for Safety Assessment Safety Monitoring - the Authority Perspective COURSE LEADERS
Peter Ravn Brink, Novo Nordisk A/S, Denmark Leslie Krause, Ferring Pharmaceuticals A/S, Denmark
LECTURERSThe Medicademy Pharmacivigilance Faculty employs ¬lecturers from all over Europe, including the Pharma¬¬- ceutical Industry, the EMA, National Authorities, Universities and Organisations. All lecturers work within their teaching area and are experts within their field. Prerequisites:ENTRY REQUIREMENTS
In order to maintain a professional level in the programme, applicants are required to have, as a minimum, a relevant Bachelor Degree and 2 years of experience within pharmacovigilance from the pharmaceutical/biotech industry or regulatory authorities, or similar qualifications. Applicants, who do not meet the entry requirements, will be considered on a case-by-case basis. Lack of formal qualifications need not be a barrier to study, and exemptions may be granted case by case. For each module, Medicademy will accept for up to 20 % of the seats to be occupied by applicants with limited experience within the pharmacovigilance area, as long as they are able to benefit from and actively participate in the module activities. Approximately 25 applicants will be admitted to each module. Please note that applications will be considered in order of receipt. |