Webinars >>Opioid Regulations
Opioid Pain Management, FDA Regulations and Requirements for Good Clinical Practice

Opioid painkillers are an important component of pain management. However, opiates are also highly likely to be abused by patients and lead to addiction. Opiate overdose kills almost twice as many people every year than heroin overdose. According to FDA and CDC it is important that doctors, pharmacists and manufacturers take special measures to control opioid abuse by their patients. Both Agencies have released new guidelines to suggest best practices for labeling of opioid drugs, prescribing such drugs to patients and increasing the use of non-opioid pain management tools. It is important for the industry and prescribers to accurately understand these new rules and regulations governing controlled substances used in pain management so that compliance can be adequately achieved.
Areas Covered in the Session:

Part 1: New Rules for Opioid Drug Labeling, Testing and Marketing
  • History of FDA regulation of opioid drugs for cancer and non-cancer pain
  • New requirements for abuse deterrent products
  • FDA’s three new guidance documents on labeling of IR and ER/LA formulations
  • New testing requirements for generic opioid drugs
  • Best practices for marketing opioid drugs to patients and prescribers
  • Pharmacovigilance requirements for opioid drugs

Part 2: Best Practices for Pain Management
  • Regulation and Requirements for Good Clinical Practice for prescribing opiate
  • Diagnosing opioid misuse & abuse
  • Appropriate Pain Management and Preventing Opioid Abuse
  • Criteria for evaluating need for opioid medication
  • CDC recommended non-opioid pain management tools and practices
  • Best practices for follow-up with patients on opioid medication
  • Use of abuse deterrent products
  • Measures to reduce and discourage forged prescriptions by patients
  • Practical tips for transition to new rules with old patients
Why should you attend:
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This one of a kind webinar by expert speaker Dr. Mukesh Kumar is intended to help the pharmaceutical industry and physicians get a better insight into FDA’s expectations concerning opioid pain management. The session will help you understand and adequately implement the current regulatory requirements concerning opioid pain management. First part discusses the new rules for labeling, testing and marketing of opioid pain killers, both new and generic that all manufacturers need to follow. The second part discusses the guidelines for physicians and pharmacists regarding best practices for diagnosing needs for opioid drugs, prescription practices, and lists of information to be collected from patients before, during and after opioid prescriptions are dispensed. This webinar will provide precise and complete discussion of current regulatory requirements in context of previous practices to assist speedy transition to new rules. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the new rules and practical tips for complying. 
Who will benefit:
  • Manufacturers of opioid drugs
  • GMP personnel
  • Regulatory affairs personnel
  • Physicians
  • Pharmacists
  • Vice presidents, Directors and Managers
  • Patients on pain killers
Date: March 29, 2019
Time: 12 PM ET        
​Duration: ​90 Minutes

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com