At the conclusion of the DIA 2019 Global Annual Meeting, participants should be able to:
- Discuss the role of Real World Evidence (RWE) in medical product development and throughout the product lifecycle
- Identify challenges and emerging standards and methodologies to ensure the appropriate use of real world data in developing evidence for regulatory decision-making and lifecycle applications
- Discuss the role of big data and analytics, approaches, and methodologies for their application throughout the product lifecycle, and legal, privacy, and security implications for their use
- Apply principles of risk assessment and management to development and post-market phases of new healthcare products
- Summarize issues in clinical safety data collection, analysis, and reporting
- Distinguish regional approaches to integration of evidence-based medicine and comparative effectiveness research into healthcare decision-making
- Describe current issues and approaches in designing and implementing clinical trials, including patient recruitment, site selection, and management of multi-regional clinical trials
- Identify current opportunities and challenges in the area of personalized medicine for disease treatment
- Describe the current and future scope of innovative technology, including wearables and other mobile devices, in the generation and collection of electronic source data in clinical research and post-market assessment to improve patient outcomes
- Compare the current regional regulatory and public policy environment pertaining to pharmaceuticals and related products
- Discuss the regulatory and economic factors that impact the global biopharmaceutical industry
- Articulate the challenges facing regulatory agencies and industry in research study design and statistical methodology in preclinical and clinical development
- Examine ways to provide appropriate support to the clinical trial process that will ultimately impact patient outcomes
- Describe meaningful engagement of patients with sponsors, regulators, and other stakeholders throughout the medical product lifecycle
- Identify policies, practices, and resources to ensure integration of the patient voice in decision-making throughout the lifecycle
- Identify relevant data, document and systems standards, and integration approaches for medical product development and explain their impact on quality and end-to-end efficiency in data collection, management, submission, and approval processes
- Identify legal, advertising, and marketing issues related to providing product information
- Discuss the evolving role of medical affairs and scientific communications in the medical product development landscape
- Examine the challenges and opportunities in assessing medical product value and access to medicines
- Interpret and apply quality standards, regulations, and guidelines for medical product development and lifecycle management to ensure that products are safe, efficacious, and available to patients who need them most
- Improve professional development and workplace dynamics by identifying best practices for increasing productivity, enhancing interpersonal relationships, valuing diversity, and keeping abreast of current hiring practices, leadership opportunities, and new technology trends
Specific learning objectives for each offering can be found on the DIA 2019 website under the program.
Select short courses and program offerings (including sessions, forums, and workshops) may be approved for AMA PRA Category 1 Credits™, pharmacy or nursing contact hours, Project Management Institute (PMI) professional development units (PDUs), or International Association for Continuing Education and Training (IACET) continuing education units (CEUs). Continuing education credit information will be clearly identified in the final program and on the DIA 2019 website with the statement CME, Pharmacy, Nursing, or PMI PDUs. IACET continuing education units (CEUs) are offered for most program offerings. CE credits are not available for the Engage and Exchange sessions, Innovation Theater presentations, Content Hubs, Posters, or Community Rounds.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and DIA. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
The Postgraduate Institute for Medicine designates this live activity for a maximum of 24.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 24.25 contact hours.
California Board of Registered Nursing
Provider approved by the California Board of Registered Nursing, Provider Number 13485, for 24.25 contact hours.
Accreditation Council for Pharmacy Education (ACPE)
DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 24.25 contact hours or 2.425 continuing education units (CEUs).
List of ACPE UANs
ACPE Credit Requests MUST BE SUBMITTED by Friday, August 9, 2019.
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 DIAs 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 Obtain your NABP e-Profile (https://nabp.pharmacy/)
Project Management Institute (PMI)
DIA has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI). Participants may receive up to 15.75 professional development units (PDUs) for attending the Annual Meeting program offerings.
List of PMI Numbers
The PMI Registered Education Provider logo is a registered mark of the Project Management Institute, Inc.
International Association for Continuing Education and Training (IACET)
DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET). DIA is authorized by IACET to offer up to 2.4 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.
As an IACET accredited provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard.
Continuing Legal Education
For attorneys who would like to receive continuing legal education credits for attending DIA 2019. If you require additional information, please contact CE@DIAglobal.org.
Statements of Credit
Participants who would like to receive continuing education credit for DIA 2019 must scan their DIA name badge at each offering to record their attendance. Participants must scan their badges within 45 minutes for the 1.5 hour offerings, 30 minutes for the 1 to 1.25 hour offering, sand 15 minutes for the 30-minute offerings. Participants who do not scan their badges within the allotted time will not be eligible to request the available continuing education credits for that offering. If a participant attends multiple offerings within the same timeframe, only the last scanned entry will be recorded.
Further instructions for requesting your statement of credit will be provided in the final program.
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 DIA. 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.
Disclosure of Conflicts of Interest
The Postgraduate Institute for Medicine (PIM) and DIA require instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by PIM and DIA for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations. Disclosure statements will be included on a slide in each meeting room, as well as on the DIA 2019 website.
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.
Read DIA’s Grievance Policy.