CMC Workshop 2015
Apr 13 2015 7:00AM - Apr 15 2015 12:00PM | Hyatt Regency Bethesda
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814-5326
The Drug Information Association (DIA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 12 contact hours or 1.2 continuing education units (CEU’s). Type of activity: Knowledge
ACPE CREDIT REQUESTS MUST BE SUBMITTED BY THURSDAY, MAY 28, 2015
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. If ACPE credit is not requested by Thursday, May 28, 2015, the CEU request will not be transmitted through to the CPE Monitor. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.
DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).
As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer 1.7 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
DIA’s Certificate Program
This program is part of DIA’s Certificate Program and is awarded the following:
• Project Management Certificate Program: 8 Elective Units
• Regulatory Affairs Certificate Program: 10 Elective Units
For more information go to www.DIAGlobal.org/certificateprograms
CONTINUING EDUCATION PHARMACY ALLOCATION
The following sessions are approved for ACPE credit:
• Session 1: Lifecycle Management: 1.5 contact hours or .15 CEUs; 0286-0000-15-048-L04-P
• Session 2B: Post-Approval Change Management Protocols (PACMP): 1.5 contact hours or .15 CEUs; 0286-0000-15-049-L04-P
• Session 4: Control Strategy Approaches for Drug Substance and Drug Product: 2 contact hours or .2 CEUs; 0286-0000-15-050-L04-P
• Session 5B: Risk-based Review: 1.5 contact hours or .15 CEUs; 0286-0000-15-051-L04-P
• Session 6B: Breakthrough Therapies: 2 contact hours or .2 CEUs; 0286-0000-15-052-L04-P
• Session 6C: Comparability Biologicals: 2 contact hours or .2 CEUs; 0286-0000-15-053-L04-P
• Session 8C: Risk Management for Biologicals: 2 contact hours or .2 CEUs; 0286-0000-15-054-L04-P
• Session 9B: Pediatrics: 1.5 contact hours or .15 CEUs; 0286-0000-15-055-L04-P
• Session 9C: Clinically Relevant Specifications: Technical Considerations and Regulatory Expectations: 1.5 contact hours or .15 CEUs; 0286-0000-15-056-L04-P
|CMC Workshop 2015
|CMC Workshop 2015
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must sign in at each session you attend, and complete the on line credit request process through My Transcript. To access My Transcript, please go to www.DIAGlobal.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, April 29, 2015.
View DIA’s Grievance Policy, at www.DIAGlobal.org/CE.
The CMC Workshop offers interested companies the opportunity to exhibit with a tabletop display.
Tabletop Fee $1,500
- One six-foot skirted table
- One chair
- Standard electricity
Attendee registration is not included in the exhibit table fee. Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.
Tabletop Exhibit Dates
April 13-15, 2015
- IPQ Publications
- Member Government
- Member Academia
- Member Standard
- NonMember Government
- NonMember Academia
- NonMember Standard
Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.
Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
AAPS Members can register at the DIA Member rate – to do so, please contact Customer Service:
Toll Free 1.888.257.6457
Monday-Friday 8:30AM-8:00PM ET
CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:
- Member or Nonmember = $200
- Government or Academia or Nonprofit (Member or Nonmember) = $100
- Tutorial (if applicable) = $50
Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.