FDA Guidance for use of Social Media by Regulated Industries (Updated to include Recent Guidance from FDA)
Instructor: Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco and tobacco-related (e-liquid, cigars).
Functions that are applicable include marketing, regulatory affairs, compliance, sales, manufacturing, Quality Control, clinical study management, labeling, adverse events management and post-marketing surveillance.
You should attend this webinar if you are responsible for planning, executing or managing the processes related to using social media to post product-related information.
Why should you Attend:
The first two guidance documents are:
- Fulfilling Regulatory Requirements for Post-marketing Submissions of Interactive Promotional Media for Prescription Human & Animal Drugs & Biologics - January 2014
- Internet/Social Media Platforms with Character Space Limitations - Presenting Risk & Benefit Information for Prescription Drugs & Medical Devices - June 2014
- Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs & Medical Devices - June 2014
- Addressing Misinformation About Medical Devices & Prescription Drugs - Questions and Answers - Guidance for Industry - July 2024.A fourth DRAFT guidance from FDA will be discussed. This draft will replace the third guidance listed above, Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices - June 2014
We will also take a look at social media regulations from various areas of the world, where countries have implemented guidelines and requirements similar to those by FDA in the US. Finally, we’ll discuss the role of the Federal Trade Commission (FTC), as it continues working with FDA to fine-tune regulations.
Areas Covered in the Session:
- Pros and cons of using social media venues
- Compliant use of Social Media in an FDA-regulated Environment
- FDA draft guidance documents
- Balancing benefit and risk information on social media
- Managing character space limitations on social media
- Managing misinformation posted by independent third-parties
- Pending regulatory action by the US Congress
- Q&A
Who Will Benefit:
- Website Administrators
- Legal
- Marketing
- Information Technology Analysts
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in the internal inspection
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.