Regulatory and Related Activities through the Device Lifecycle
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Regulatory and Related Activities through the Device Lifecycle Course
Introduction:
The market for medical devices has grown in size in recent years, and this growth is expected to continue.
The goal of this course is to help regulatory affairs professionals gain a deeper grasp of a range of subjects that are crucial to maintaining the legal and commercial viability of their company's medical devices after they have been successfully marketed.
Advertising, data security and privacy, patents and intellectual property, health technology evaluation and payment, environmental laws and regulations, trade associations, authorized representatives, distributors, own-branders, product supply and logistics, product liability law, surprise audits, and good regulatory practices are among the subjects covered.
Course Objectives:
By the end of this Regulatory and Related Activities through the Device Lifecycle training course you will be able to:
- Understand medical devices and their classification
- Clarify procedures for company and product registration
- Discuss recent developments in the region
- Meet, network and share experiences with other industry colleagues
- Demonstrate the ability to critically analyze the legal, regulatory and quasi-regulatory requirements applying to medical devices
- Apply good regulatory practice, particularly when interacting with regulatory bodies, including critically appraising communications
- Make recommendations about how to prepare for unannounced audits
- Deal with complex issues both systematically and creatively, make sound judgments in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences
- Demonstrate a critical understanding of the factors required to maximize the success of a medical device
- Understand the importance of intellectual property, data protection and product liability and judge when legal
Who Should Attend?
- Anyone involved in regulatory affairs for medical devices
- Anyone new to the region
- Anyone interested in an update on recent developments
Course Outlines:
The medical device markets
- Markets and Culture
- Healthcare
- Business culture
Regulatory environment and characteristics
- General regulatory requirements
- Company and product registration
Key documents needed
- Basic structure of a dossier
- Regulatory summary
Management of adverse incidents
- Definitions: what is reportable, the reporting
- process and investigation
- Corrective action
- Periodic safety update reports – how to manage this requirement
Intellectual Property Law
- Advertising and Promotional Issues
- Data Privacy & Protection Freedom of Information and transparency