Continuing Education Credits
At the conclusion of this meeting, participants should be able to:
- Define how the evolving health care environment will affect orphan product development and investment
- Discuss how the government and private sector are addressing the special challenges faced by patients and companies under the Affordable Care Act and other changes in how health care is delivered and financed
- Express ideas on best practices for patients with rare diseases and the organizations that represent patients
- Discuss how to enhance communication among the investigator, patient, industry, investor and government influencers in the rare disease/orphan product community
- Discuss the latest initiatives in rare disease and orphan drug/device research and development
- Identify how FDA is implementing new legislation related to the review and approval of orphan drugs and humanitarian devices
- Discuss case studies which illustrate how industry, government and patients are collaborating to advance the development and approval of new therapies
- Explain the new initiatives in developing natural history studies, new methods of conducting clinical trial design and statistical analysis, endpoint development, and post-marketing opportunities
- Recognize the importance of collaboration in rare disease drug and device development
- Discuss the challenges faced in managing orphan drug shortages, paying for orphan therapies, and working with patients on obtaining access to special medicines
The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 4.5 contact hours or .45 continuing education units (CEU’s). Type of Activity: Knowledge
ACPE Credit Requests
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. 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.
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; (703) 506-3275.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer up to 2.0 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.
IACET CREDIT ALLOCATION
Tutorial: Overview of The Regulatory frameworks and Opportunities for Orphan Medicinal Products (OMPs): .3 IACET CEUs
US Conference on Rare Diseases and Orphan Products: 1.7 IACET CEUs
If you would like to receive a statement of credit, you must attend the conference, sign in each day and if applicable, at the three designated ACPE-certified sessions (see PHARMACY CREDIT ALLOCATION), and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.diahome.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, October 23, 2013.
This program is part of DIA’s Certificate Program and is awarded the following:
For more information go to www.diahome.org/certificateprograms
PHARMACY CREDIT ALLOCATION
- Clinical Research Certificate Program: 12 Elective Units
- Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
- Regulatory Affairs Certificate Program: 12 Elective Units
October 8; Track 3: Paying for Orphan Therapies: 1.5 contact hours or .15 CEUs, 0286-0000-13-085-L04-P
October 8; Track 2 and 3: Assuring Patient Access to Treatments: 1.5 contact hours or .15 CEUs, 0286-0000-13-086-L05-P
October 9; Track 3: Managing Orphan Drug Recalls and Shortages: 1.5 contact hours or .15 CEUs, 0286-0000-13-087-L01-P
It is Drug Information Association 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. Faculty disclosures will be included in the course materials.
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that 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.
View DIA’s Grievance Policy.
AMERICANS WITH DISABILITIES ACT (ADA)
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.