TRAINING CALENDAR 2018 Quality Efficiency Innovation
CLINICAL RESEARCH AND COMPLIANCE 9 July Data Integrity Assessment WORKSHOP An effective approach to identify data integrity gaps on some pratical examples and to define appropriate corrective actions MEDICAL WRITING 5-6 April COPENHAGEN Denmark Successful Publication Writing How to plan and prepare successful medical publications 18 June Writing a compliant and effective Clinical Study Report 19 June Writing effective technical reports in English for scientists and engineers in the biosciences 29-30 October Successful Publication Writing How to plan and prepare successful medical publications THE COURSE DATES ARE SUBJECT TO CHANGE. FOR MORE DETAILS VISIT THE WEBSITE [ TRAINING CALENDAR - 2018 ] PAGE 1/4
OBSERVATIONAL CLINICAL RESEARCH 10 April The use of Patient Reported Outcomes (PRO) for Real World Evidence generation 19-20 June PARIS France Real World Data Generation: Methods, Strategy & Design 9 October ZURICH Switzerland Real World Data as a key opportunity for drug development and Market Access 13-14 November COPENHAGEN Denmark Real World Data Generation: Methods, Strategy & Design REGULATORY AND COMPLIANCE 4-5 April Advanced European Regulatory Affairs Update on the developments in Europe for Regulatory Affairs and the impact on product development and life cycle management 29-30 October esubmissions: update on all Telematics projects and the impact on regulatory processes and companies Get informed about the latest status of all EU projects on electronic submission, ranging from ectd, eaf, CESP, xevmpd, SPOR and ISO IDMP [ TRAINING CALENDAR - 2018 ] PAGE 2/4
PHARMACOVIGILANCE AND COMPLIANCE 26 March Good Vigilance Practices: module VI and EU reporting system Practical aspects, criticality and possible solutions 10-11 April AMSTERDAM The Netherlands Social Networks for Pharmacovigilance: different approaches for managing signals from ICRS to Twitter 03-04 July Pharmacovigilance documents in the life cycle of a medicinal product: DSUR, RMP, PSUR/PBRER, and Addendum to the Clinical Overview From patients to health authorities: data collection, signal management, document preparation, authority assessment 13-14 September COPENHAGEN Denmark Pharmacovigilance documents in the life cycle of a medicinal product: DSUR, RMP, PSUR/PBRER, and Addendum to the Clinical Overview From patients to health authorities: data collection, signal management, document preparation, authority assessment CROSS-FUNCTIONAL 12 June Communicating Effectively With Foreign Partners How to bridge cultural differences and improve international collaborations 21 September PARIS Communicating Effectively With American Partners France How to become familiar with American business culture and improve collaborations with American partners? THE COURSE DATES ARE SUBJECT TO CHANGE. FOR MORE DETAILS VISIT THE WEBSITE [ TRAINING CALENDAR - 2018 ] PAGE 3/4
MEDICAL DEVICE AND COMPLIANCE 26-27 June VIENNA The New EU Regulation 2017/745 on Medical Devices Austria Understanding the Regulation and its impact on Industry [ TRAINING CALENDAR - 2018 ] PAGE 4/4
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