Opioid Pain Management - FDA's Role, Regulations and Recent Approvals

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Length
60 minutes
Product Description

Learn About Appropriate Opioid Pain Management, FDA Regulations and Requirements for Good Clinical Practice

It is important for the industry to accurately understand FDA roles and regulation governing controlled substances so that compliance can be adequately achieved.

This webinar by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA is intended to help the pharmaceutical industry get a better insight into FDA’s expectations concerning opioid pain management. The session will help you understand and adequately implement the regulatory requirements concerning opioid pain management.

Session Highlights:

  • Laws and Regulations
  • Definitions
  • Regulation of Controlled substances according to FDA
  • Regulation and Requirements for Good Clinical Practice
  • Regulating Abuse-deterrent Opioid Medications
  • Opioid Misuse & Abuse
  • Appropriate Pain Management and Preventing Opioid Abuse
  • Best Practices

 Training content:

  • The Controlled Substances Act of 1970
  • Title 21 CFR Food and Drugs (Current as of April 16, 2015)
  • CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, Department of Justice
  • Regulations to Be Aware
  • Narcotic Drug: 21 CFR 1300.01
  • US DOJ and DEA Administrator in 2011
  • Heroin (Brain Hostage Taker) Structure
  • FDA’s High Public Health Priority: Developing Abuse-Deterrent Opioids
  • Timeline of FDA Activities and Significant Events (Selected)
  • FDA’s Current Thinking
  • Totality of the Evidence for Magnitude of Effect
  • FDA Guidance: Relevant and Applicable for Opioid Pain Management
  • FDA Guidance: Analgesic Indications: Developing Drug and Biological Products
  • FDA Guidance: Abuse-Deterrent Opioids - Evaluation and Labeling
  • Good Clinical Practice (GCP) Guidance to Note
  • Good Clinical Practice (GCP) Regulations
  • FDA Approved Opioids with Abuse Deterrent Labeling

Who Should Attend

  • Global medical and pharmaceutical industry
  • Healthcare industry management
  • Healthcare industry professionals
  • Control substance and pain management industry
  • Opioid users, caregivers and pain management professionals
  • Compounding pharmacy

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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