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SUMMARY:Healthcare CoP April 2018: Hammers\, VAS\, and the Government - Wha
 t you need to know about Opioids
DESCRIPTION:
 Abstract
 Deadly drug overdoses have more than doubled in t
 he United States since 1999.&nbsp\; This is no longer a problem with just 
 the poor and uneducated\, and it now effects all areas of our society.&nbs
 p\; It has been stated that we are in an “opioid epidemic.”&nbsp\; As 
 a result\, the government is seeking solutions to the problem and many com
 panies are devoting R&amp\;D efforts to develop abuse deterrent formulatio
 ns (ADFs).
 Formulation aspects that render a product with abuse deterren
 t characteristics are quite varied\, and several different approaches have
  been approved by the FDA.&nbsp\; The agency continues to support sponsors
  in their development of the products and two FDA guidance documents\, Abu
 se Deterrent Opioids – Evaluation and Labeling (April 2015) and the rece
 ntly published General Principles for Evaluating the Abuse Deterrence of G
 eneric Solid Oral Opioid Drug Products (November 2017)\, detail guidelines
  for the development of these products and explain the current regulatory 
 thoughts on the requirements for new products upon submission.&nbsp\;
 In
  vitro evaluations to evaluate the ability to manipulate the prescription 
 medicines to rapidly release the opioid and the in vivo clinical likabilit
 y studies will be discussed with an emphasis on how they are conducted and
  what you can expect as a result.&nbsp\;&nbsp\;&nbsp\;
 Learning Objectiv
 es:
 Attendees will get a better understanding for the following:
 1.&nb
 sp\;&nbsp\;&nbsp\;&nbsp\;&nbsp\; Why the need for abuse deterrent formulat
 ions?
 2.&nbsp\;&nbsp\;&nbsp\;&nbsp\;&nbsp\; What are abuse deterrent for
 mulations?
 3.&nbsp\;&nbsp\;&nbsp\;&nbsp\;&nbsp\; Current regulatory land
 scape for abuse deterrent formulations
 4.&nbsp\;&nbsp\;&nbsp\;&nbsp\;&nb
 sp\; Testing required for abuse deterrent formulations
 
LOCATION:7001 Weston Pkwy #100\, Cary\, NC 27513\, USA
DTSTART:20180404T213000Z
DTEND:20180404T233000Z
DTSTAMP:20260404T071159Z
ORGANIZER;CN=PMI North Carolina Chapter:MAILTO:bounce@ncpmi.org
GEO:35.828363;-78.791424
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