This webinar will provide highlights of draft and recently approved regulations for awareness of potential impact to your global operations. This includes the revisions to the EU GVP Module IX guideline, SPL in Canada, updating of labeling in Japan and device regulations in the EU.
Continuing Education Credits are not available for this event.
精选主题
• Labeling Regulation and Guidance Changes Globally
谁应该参加?
Professionals from biopharmaceutical and device companies, regulatory authorities, CROs, and consulting agencies involved in:
Labeling
Clinical Safety/pharmacovigilance
Pharmacoepidemiology
Regulatory affairs/drug review and approval process
Medical affairs and communications
Medical writing
Clinical research and development
Product research and development alliances
Quality control/quality asssurance
学习目标
At the conclusion of this webinar, participants should be able to:
Identify new or recently revised regulations impacting labeling
Identify potential impact of regulation/guidance changes on participants’ labeling operations
Understand how these issues shaped the agenda for the DIA Global Labeling Conference in April 2018