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
- 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 Should Attend:
- Healthcare Practitioners
- Pharmacy Professionals
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Research & Development
- Anyone Interested in the Opioid and Pain Management
Course Director: 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.