Horsham, Pa. — June 17
DIA has partnered with Thomson Reuters to build upon its library of e-learning modules for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related health care products.
DIA members and customers will now have access to Thomson Reuters IDRAC Regulatory Affairs eLearning Modules.
“Our constituents represent a diverse group of global health care professionals all coming together to achieve their common professional aspirations essential to innovation in today’s health care environment,” says DIA Worldwide Executive Director Paul Pomerantz. “IDRAC’s global reach, depth of analysis and local expertise supports our commitment to providing in-depth knowledge of every regulation that could affect the discovery, development and delivery of health care products around the world.”
DIA and IDRAC will deliver e-learning modules focusing on a variety of topics, including:
• Access to Unapproved Drugs through Compassionate Use.
• Regulatory Requirements for the Conduct of Clinical Trials in Europe.
• Orphan Drugs in Europe, USA and Japan.
• Regulatory Requirements for the Submission of Investigational New Drug Applications in the USA (INDs).
• Meeting Opportunities with Regulatory Agencies.
• Introduction to the European Union Institutions and Regulatory Authority.
• Introduction to US Institutions and Regulatory Authority (FDA).
• Introduction to Japanese Institutions and Regulatory Authorities.
• Overview of the CTD and the eCTD.
• Introduction to the International Conference on Harmonization (ICH).
• The Regulatory Development Cycle of a Drug.
• Basics of Pharmacovigilance.
• Basics of Clinical Trials.
• How to Register Medicinal Products through the Centralized Procedure.
• How to Register Medicinal Products through the Mutual Recognition Procedure.
• How to Maintain Marketing Approvals in Europe for Centrally Authorized Products.
• How to Register a New Drug in the USA.
• How to Register Medicinal Products through the Decentralized Procedure.
DIA eLearning modules are available anytime. DIA courses are engineered for effective, interactive and self-paced learning.
Source: DIAFiled under: Technology