$1,885 – $5,675

4th Human Abuse Liability & Abuse-Deterrent Formulations (EXL)

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4th Human Abuse Liability & Abuse-Deterrent Formulations

In spring 2016, the FDA released the long-awaited draft guidelines that brought generic drug manufacturers into the abuse-deterrent formulations market. This new regulatory framework comes at a time when public concerns about abuse of prescription opioids has never been higher — and yet obstacles to market uptake remain due to payer and prescriber hesitancy. This period of upheaval is why you cannot afford to miss the 4th Human Abuse Liability & Abuse-Deterrent Formulations conference — the largest and most specifically focused educational event devoted to improving trial designs, engineering less abuse-prone molecules and delivery systems, and tracking the performance and market uptake of opioids in order to document the success of abuse-deterrent methods. Over the past four years this event has brought more than 200 industry leaders together, and this year is going to have our most in-depth educational and networking opportunities yet!

Top Five Reasons to Attend

  1. Insight on the latest regulatory guidelines for branded and generic opioids
  2. Lessons learned from FDA advisory committee meetings
  3. State-of-the-art reviews of prodrug technologies, agonist/antagonist formulations and novel delivery mechanisms
  4. Techniques to find and document the data showing the uptake and abuse rate of specific opioid types
  5. A way forward to make the case to payers, patients and physicians that your opioids are truly less of an abuse risk

Who Should Attend

This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas:

  • Regulatory Affairs/Intelligence
  • Epidemiology/Pharmacoepidemiology
  • 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
  • R&D
  • Pharmacovigilance
  • Pharmacoeconomics/Health Outcomes/Outcomes Research/HEOR
  • Commercial Affairs
  • Legal Affairs/Legal Counsel

In addition, this conference is 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
  • IP Service Providers


Sponsors

The 4th Human Abuse Liability & Abuse-Deterrent Formulations conference will be the largest and most specifically focused event in the world devoted entirely to designing, testing and marketing prescription drugs with a lowered risk of abuse.


Alcami

Alcami is a world-class supplier of comprehensive pharmaceutical development and manufacturing services headquartered in Wilmington, NC. We provide flexible, transparent and innovative services to small and mid-size pharma and biotech companies by offering individualized and integrated services across Active Pharmaceutical Ingredients (APIs), Drug Product, Development Services, and Analytical Testing. We strive to be the most customer-focused and reliable partner built on safety, compliance, strong scientific expertise and leading technologies.


DrugScan

DRUGSCAN©’s CAT.one™ laboratory-based manipulation and extraction studies are designed and conducted to produce data that can predict a product’s strengths and weaknesses to physical and chemical manipulations as well as support abuse-deterrent label claims. Employing state of the art technology and abuse-deterrent testing expertise, DRUGSCAN© has been at the forefront of designing and conducting manipulation and extraction studies for many of the leading abuse-deterrent product developers in the US and around the world.


PRA Health Sciences

PRA Health Sciences’ early phase professionals live and breathe clinical pharmacology. As the most comprehensive high-end Phase I CRO in the world, PRA Early Development Services provide the unique scientific environment required for complex compound development in both healthy volunteers and special patient populations. Committed to the highest standards of clinical excellence and scientific expertise, we operate state-of-the-art facilities in The Netherlands and North America as well as an innovative patient pharmacology model in Central and Eastern Europe. Our fully harmonized, GLP-compliant laboratories are located close to our clinical units, enabling us to quickly analyze time-critical samples.


RADARS System

The RADARS® System collects timely product- and geographically specific prescription drug abuse, misuse and diversion data utilizing a mosaic strategy across all phases of the drug abuse pathway and provides these data to the pharmaceutical industry, regulatory agencies, policymakers and medical/public health officials. Additional RADARS® System services include postmarket surveillance, epidemiological studies, publication strategy, advisory committee consultation and advisory board participation. The RADARS® System is a governmental nonprofit operation of Denver Health and Hospital Authority.


The Grünenthal Group: International, Successful, Innovative

The Grünenthal Group is an independent, research-based pharmaceutical company headquartered in Germany. Grünenthal is present in 32 countries with 5,300 employees worldwide. In 2014 revenues were approximately $1.25 billion. Since 2010, Grünenthal has marketed its proprietary abuse-deterrent technology INTAC®, which restricts manipulation and impedes abuse due to high mechanical stability.


Vince & Associates Clinical Research

Altasciences Clinical Research encompasses Algorithme Pharma and Vince & Associates Clinical Research, making it one of the largest early phase clinical CROs in North America. With more than 25 years of experience, Altasciences provides clinical development services to biopharmaceutical companies worldwide, including study conduct, medical writing, biostatistics, data management and bioanalysis.


Event Partners


MEDtube

PharmaLeaders

pharmaphorum.com

PharmaVOICE

PM360

Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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