Opioid and Pain Management: FDA Perspectives and Requirements

The United States Food and Drug Administration (FDA) recently expressed deep concerns over the growing epidemic of opioid dependence, overuse and abuse on families and communities.

Opioids as prescription drugs are used to reduce chronic pain. Opioids offer both great benefits and also serious risks, potentially causing serious harm (addiction, overdose and even death) when misused or abused.

This seminar is intended to help industry and professionals to better understand FDA roles and regulation governing controlled substances (opioids) used for pain management. This seminar is also intended to help industry get better familiar with FDA’s recent activity and regulatory expectations for drugs (opioids) including generic opioids and recent approvals for pain management.

The speaker will guide you through the details of FDA roles, regulations, generic opioids and recent FDA approvals for chronic pain management.

Areas Covered in the Session :
Applicable Laws, Regulations and FDA Guidance
Major Misconception
Definitions
Regulations Governing Controlled Substances
Abuse-Deterrent Opioid Medications
Opioid Misuse & Abuse
New Labeling Requirements
FDA Approved Opioids: Generics and ER/LA Opioids
Prevention of Opioid Abuse
Appropriate Pain Management
Speaker’s PASS-IT Recommendations: Best Practices

Who Will Benefit:
Healthcare Practitioners
Pharmacy Professionals
CEOs
VPs
Compliance Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
Research & Development
Consultants
Contractors/Subcontractors
Anyone Interested in the Opioid and Pain Management

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance