- Date: April 3, 2018
- NOTE: This seminar recurrs tri-monthly (every three month) on 1st Tuesdays.
- Your payment will apply for the next upcoming LIVE online seminar unless requested otherwise after registration.
- Time: 01:00 PM PST | 04:00 PM EST
- Duration: 60 Minutes
About the Seminar
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.
In this 60-min presentation, the speaker will guide you through the details of FDA roles, regulations, generic opioids and recent FDA approvals for chronic pain management.
About the Areas to Be Discussed
- FDA Laws and Regulations
- Learn About Controlled Substances
- Regulation of Abuse-Deterrent Opioid Medications
- Opioid Misuse & Abuse
- Prevention of Opioid Abuse and Appropriate Pain Management
- New Labeling Requirements
- FDA Approved Generic Opioids
- Recent FDA Approvals for Pain Management Drugs
- Best Practices
About the Intended Attendee(s)
- Regulatory Affairs
- Research and Development
- Clinical Affairs
- Senior Management
- Contractors and subcontractors
- Medical Doctors and Healthcare Professionals
- Anyone interested in the topic
About the Seminar Speaker
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products. In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.
Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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 seven 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. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the advisory board for inspection insider at FDA News.
- Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
- Option 2: you may request an invoice by email to Global Compliance Seminar
- Option 3: you may purchase online below using a credit card or PayPal.
LIVE (one attendee): $299
LIVE (≤ 4 attendees): $799
LIVE (≥ 5 attendees): $999
LIVE & Recorded: $399