At the conclusion of DIA 2018, participants should be able to:
- 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
- Recognize the challenges facing regulatory agencies and industry in research study design and statistical methodology in preclinical and clinical development
- 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
- 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 postmarket assessment to improve patient outcomes
- 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
- 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
- Identify legal, advertising, and marketing issues related to providing product information
- Apply principles of risk assessment and management to development and post-market phases of new healthcare products
- Summarize issues in safety reporting and data analysis regarding adverse events
- Distinguish regional approaches to integration of evidence-based medicine and comparative effectiveness research into healthcare decision-making
- Describe current issues in designing and implementing clinical trials, including patient recruitment, site selection, and management of multi-regional clinical trials
- Discuss the evolving role of medical affairs and scientific communications in the medical product development landscape
- Identify current opportunities and challenges in the area of personalized medicine for disease treatment
- Examine ways to provide appropriate support to the clinical trial process that will ultimately impact patient care
- Examine the challenges and opportunities in assessing medical product value and access to medicines
- 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
- 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
Specific learning objectives for each offering will be found on the DIA 2018 website under the program in the coming months, please check back.
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 2018 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, or the Opening Plenary session.
Accreditation Council for Continuing Medical Education (ACCME)
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine (PIM) and the Drug Information Association (DIA). PIM is accredited by the ACCME to provide continuing medical education for physicians.
Accreditation Council for Pharmacy Education (ACPE)
DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
American Nurses Credentialing Center (ANCC)
PIM is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
DIA has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI).
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).
Continuing Legal Education
For attorneys who would like to receive continuing legal education credits for attending DIA 2018, please complete your state’s application for credit and submit accordingly. If you require additional information, please contact CE@DIAglobal.org.
Statements of Credit
Participants who would like to receive continuing education credit for DIA 2018 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, and 30 minutes for the 1.25 hour 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 2018 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.