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

Date: May 7 , 2025
Duration: 60 Minutes
Time: 12 PM EST

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:
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

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.