4th Human Abuse Liability & Abuse-Deterrent Formulations – 4th Human Abuse Liability & Abuse-Deterrent Formulations

The opioid addiction crisis is rising out of control and leading to an increase in political and market pressure on drug companies from regulators, legislators, insurers, physicians, and patient advocacy groups. ExL’s 4th Human Abuse Liability & Abuse-Deterrent Formulations conference is the largest industry event specifically focused on the full spectrum of challenges and goals required to create and market drugs with lowered abuse potential. No other event goes into as much detail about the preclinical development of abuse-deterrent drugs and delivery mechanisms, clinical trial design, and building strong, reliable networks with every stakeholder throughout the regulatory and market access community.

NEW FOR 2017: DINNER WORKSHOP

Anticipate the Greatest Challenges When Facing FDA Advisory Committee Meetings

Under the 21st Century Cures Act, every new opioid will need to clear an FDA advisory committee meeting. Preparing for these meetings can be costly and difficult, especially given the level of background knowledge of committee members. This interactive workshop helps you set expectations for practice meetings, adapt to the likely knowledge and skill levels of committee reviewers, pick the best scientific evidence and language, fine-tune your rapid response tools, and more.

Presented by:

 

Dan Cohen, Forum Chair, ABUSE DETERRENT COALITION; Executive Vice President, Government Relations, KEMPHARM Ernest Kopecky, Vice President, Clinical Development, Head, Global Pain Medicine, TEVA

Top Five Reasons to Attend

  1. All-new insight on how to gather and use real-world evidence to make a strong case for your ADFs among payers and clinicians
  2. Technical analysis of the next generation of less addictive opioids
  3. Up-to-date review of the latest FDA regulatory guidelines and public meetings
  4. Detailed survey of new state legislation about opioids and manufacturers
  5. In-depth, interactive workshop about preparing for an FDA advisory committee meeting

Who Should Attend

This conference is aimed at biopharma and medical device professionals responsible for:

  • Regulatory Affairs / Intelligence
  • Epidemiology / Pharmacoepidemiology
  • Abuse / Deterrent / Deterrence / Abuse deterrent / Abuse Deterrence
  • Clinical Development / Operations / Affairs / Programs
  • Risk Management / REMS
  • Toxicology
  • Drug Safety
  • Pharmacology / Clinical Pharmacology / Safety Pharmacology
  • CNS / Neuroscience
  • Medical Affairs
  • Scientific Affairs
  • Formulations
  • Analytical Development
  • Pharmaceutical Development
  • Clinical Development
  • Preclinical Development
  • R&D
  • Quality
  • Pharmacovigilance
  • Pharmacoeconomics / Health Economics / Outcomes Research / HEOR
  • Commercial Affairs
  • Legal Affairs / Legal Counsel

This event is also of interest to:

  • CROs
  • Toxicology Specialists
  • Drug Abuse Registry / Surveillance Specialists
  • REMS / Pharmacovigilance Specialists
  • Formulation Service Providers
  • Pharmacokinetics Service Providers
  • Abuse Liability Service Providers
  • Regulatory Specialists
  • Intellectual Property Service Providers
Startdate: 2017-11-06
End Date 2017-11-07

Description: The 4th Human Abuse Liability & Abuse-Deterrent Formulations Summit is the largest, most specifically focused educational event on improving trial designs.
Performer: ExL Events
Address : 1 Bethesda Metro Center 4th Human Abuse Liability & Abuse-Deterrent Formulations
Bethesda
MD
USA