In-vitro Diagnostics (IVD) Regulations Course: A Systematic Approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada (Boston, United States - October 14-15, 2019)
This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.
In-vitro Diagnostics (IVD) products provide critical information on patient's health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.
Learning Objectives:
After completion of this two day interactive course on IVD, the attendee will be able to:
Understand why IVD is regulated differently.
An overview of IVD Regulations - U.S. FDA., Europe (MDD), Canada.
Develop Regulatory Strategies and determine Regulatory Pathways.
Inclusion and exclusion of data and information for different submission.
Format and Content of premarket submissions.
Product Label and Labeling for IVDs.
Working and interacting with the reviewers and regulators.
Tips and Suggestions to secure rapid regulatory approvals.
Who Should Attend:
This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products.
This course is highly recommended for personnel involved in any of the following functions:
Department Managers (middle management)
Research & Development (R&D)
Product Design & Development
Validation Engineering
Regulatory Affairs
Quality Assurance
Quality Control
Manufacturing/Production
Agenda:
Day 1
Session 1: 09:00 AM - 10:30 AM
Evolving technologies and challenges of In-vitro Diagnostics (IVD) products
Why the regulators need separate regulations even IVD is considered a device?
Know the process and players at OIR (aka OIVD) of CDRH and Health Canada
Morning Break: 10:30 AM - 10:45 AM
Session 2: 10:45 AM - 12:15 PM
Overview of US-FDA Regulations for IVDs
Lunch Break: 12:15 PM - 1:15 PM
Session 3: 1:15 PM - 2:45 PM
Determination of classification & Identification of Predicate Device(s)
Development of Regulatory Strategies and Pathways for IVDs
Special consideration of IVD labeling requirements
Afternoon Break: 02:45 PM - 03:00 PM
Session 4: 03:00 PM - 04:30 PM
Determine the type of the required pre-market submission for your IVD
Format and Content of 510(k), Pre-IDE, IDE and PMA
What is a Clinical Laboratory Improvement Amendment (CLIA) of 1988?
Preparation and submission for CLIA Waiver Application
Day 2
Session 5: 09:00 AM - 10:30 AM
Overview of European IVD Regulations
Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents
Morning Break: 10:30 AM - 10:45 AM
Session 6: 10:45 AM - 12:15 PM
Special consideration to Classification Rules for IVDs
Conformity Assessment for CE Marking
Special Labeling and electronic Labeling Requirements for IVDs
Preparation of Technical File or Design Dossier
Lunch Break: 12:15 PM - 1:15 PM
Session 7: 1:15 PM - 2:45 PM
Overview of Canadian Medical Device Regulations (CMDR) for IVDs
Understanding similarities and differences between U.S. and Europe regulations
Afternoon Break: 02:45 PM - 03:00 PM
Session 8: 03:00 PM - 04:30 PM
Format and Content of Canadian Medical Device License (MDL) Application
Inclusion of the required data and information for MDL application
Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial...
The report titled "Central Lab Market by Service Type (Anatomic Pathology/Histology, Biomarker Services, Genetic Services), Phase (Phase 1, Phase 2, Phase 3), Therapeutic Area, End-use - Global Forecast 2024-2030" is now available on...
The report titled "Personalized Nutrition Market by Measurement Type (Active Measurement, Standard Measurement), Application (Indication-based, Standard Supplements), Distribution Channel, End-Use - Global Forecast 2024-2030" is now available on...
The report titled "Carbon Dioxide Incubator Market by Product (Air Jacketed CO2 Incubators, Direct Heat CO2 Incubators, Water Jacketed CO2 Incubators), Capacity (100-200 Litre, Above 200 Litre, Below 100 Litre), Application, End User - Global...
The "Global Clinical In Vitro Diagnostic Medical Laboratory Services Market: Strategy & Trends with Volume & Price Forecasts by Chemistry, Hematology, Microbiology, Pathology, Covid-19, and Molecular Dx by Country. Updated with Impact of COVID-19"...
The "Molecular Diagnostics at the Point of Care. By Application, Technology, Place, Product and by Country. With Executive Guides and Customization 2023 - 2027 " report has been added to ResearchAndMarkets.com's offering.
Infectious disease Dx is...