In recent years, big data and information is available in public domain. Adequate use of such big data in FDA-regulated industry has become critically important to exercise best practices. In this presentation, the speaker will provide a great opportunity to learn about practical, actionable and sustainable approaches to maximally use the big data. In particular, the speaker will share how to most effectively identify and use the big data for practical application to your business in FDA-regulated industry (drugs, medical devices including IVDs, dietary supplements, cosmetics, etc.). This webinar will help you bring significant benefits including detailed strategies of how to use big data to your business practices and organization, tremendously helping you save enormous resources (time, energy and money) and beyond.
In this 60-min presentation, the speaker will guide you through the details of how to identify and use big data for your maximum benefits applicable to FDA-regulated industry.
At the end of this seminar, you will learn how to develop and implement best practices to systematically use big data using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive strategy in a Systematic, Integrated Manner.
Areas Covered in the Session :
Applicable Laws, Regulations, Guidance, Rules, Standards
Definitions
Big Data Sources in Pharmaceuticals and Medical Devices
Power of Big Data
Data Mining
Drug Safety Data and Signals
Medical Device Safety Data
Solving Big Problems Using Big Data
Science Using Big Data
Big Data, Security and Privacy Matters
Big Data v. Drug Discovery
Revolution in FDA-Regulated Industry Using Big Data
Company’s Views on Big Data
Big Data: Current Trends
Big Data Driven Medicines
Big Data: Legal, Ethical and Policy Issues
Failure to Use Big Data
Inadequate Use of Big Data
Big Data Management
Big Data: Opportunities
Big Data: Challenges
Post-marketing surveillance
Systematic Use of Big Data: Best Practices
Speaker’s PASS-IT Suggestions/Recommendations
Speaker’s Experience and Actual Cases
Conclusion
Who Should Attend:
Quality Departments
Regulatory Affairs Departments
Research and Development Departments
Manufacturing Departments
Engineering Departments
Operations Departments
Production Departments
Senior Management
Marketing Departments
Product Development Professionals
Clinical Affairs Professionals
Contractors and subcontractors
Consultants
Everyone interested in the topic