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Main : Course Catalog : Pharmaceutical Regulatory Review Course |
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PHAR100-0410: Pharmaceutical Regulatory Review Course
INSTRUCTOR:
Doug Kemp, Pharm.D, DICVP.
DATES:
April 5 - April 18th, 2010
Interactive Session: Sunday, April 11; 6:00 - 8:00 pm ET (USA)
COURSE DESCRIPTION
Participants will learn the federal requirements that apply to the security and accountability for controlled substances in veterinary practices, including:
Why it is important to develop a good system for your practice
Structure of applicable federal laws and how to find them
Schedules of controlled substances
Laws pertaining to ephedrine and other list 1 substances
Registration requirements
Use of agents
Employee screening and criminal background checks
Components of a distribution system
Receiving and ordering records
Storage requirements and disposal
Disposition & dispensing records
Audit requirements and recommendations
Medical record documentation including computerized medical records
Duty to report loss or theft
Retention of records
Inspections and inspectors
Distribution to other practitioners and filling of prescriptions written by other practitioners
Penalties
The second portion of the course addresses Food and Drug issues relating to veterinary practice, including:
Structure of federal laws and regulations, and where to find them
FDA friend or foe?
Compliance policy guides
How to respond to proposed regulations or compliance policy guides
AMDUCA and when extralabel use is allowed
Compounding vs manufacturing issues
Participants will be able to evaluate their current practices and, if needed, implement improvements that reduce the risk of theft, diversion or prosecution for failure to maintain an adequate system of security and accountability for controlled substances. Participants will have a better understanding of the actions of FDA and will learn how to express their opinions to FDA. Participants will learn when they can use drugs in an extra-label manner and when they are engaging in activities that are of enforcement priority by FDA. They will also learn when they can use compounded drugs in veterinary practice.
MESSAGE BOARD DISCUSSIONS:
Discussions will begin on the start date of the course and continue for 7 days following the last real-time session. Message boards for this course will be monitored by the instructor starting Monday, April 5 (one week before the first real-time session) so that everyone may post their specific pharmaceutical questions before the real-time session. The instructor will post daily discussion questions starting April 5 and the participants are required to begin participating on the boards at that time.
CE HOURS: 3 (Accepted for Florida State Veterinary Board Pharmacy CE requirement)
**The Georgia State Board of Veterinary Medicine recently changed their requirement on their required 2 CE hours on Georgia laws, rules and professionalism. This course had been previously approved to meet this requirement, but according to the most recent board meeting, one of the two CE hours must now be acquired in person.
Please read December 2, 2009 board meeting minutes for more information: http://sos.georgia.gov/plb/veterinary/minutes.asp
TUITION:
Member/$54, Non-Member/$109 by March 22, 2010;
Member/$60, Non-Member/$121 after March 22, 2010.
NOTE: Registration will be closed when the maximum number of participants is reached.
Required Textbook:
None
Recommended Textbook:
None
For More Information on VIN's Upcoming CE Courses, check out https://www.vin.com/CE/Catalog.htm
"This course has been approved for 3 hours of continuing education credit in jurisdictions which recognize AAVSB RACE approval; however participants should be aware that some boards have limitations on the number of hours accepted in certain categories and/or restrictions on certain methods of delivery of continuing education. Call VIN at 1-800-700-4636 for further information."
COURSE WITHDRAWAL AND REFUND POLICY: Withdrawal prior to the listed start date of a course entitles the registrant to a complete refund or a credit toward a future VIN CE course, whichever is preferred. Withdrawal within 1 week after the listed start date (i.e. including no more than one real-time session) entitles the registrant to a credit toward any future VIN CE course. (Does not apply to courses with only one real-time session.) After the first real-time session, a registrant may withdraw due to special circumstances and receive prorated credit towards a future VIN course. These requests will be handled on an individual basis. The amount of the prorated credit will be determined based on 65% of the time remaining in the course at the time of withdrawal. It is not possible to withdraw retroactively. Note: To ensure rapid handling of your request for withdrawal, we recommend that you call the VIN office at 1-800-700-INFO.
Debbie Friedler
Coordinator
Continual Education Division
Veterinary Information Network
CEonVIN@vin.com
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