At the conclusion of the DIA 2020 Global Annual Meeting, participants should be able to:
- Discuss the use of Real World Evidence (RWE) in regulatory decision-making, the current standards and methodologies for generating real world data (RWD), and how RWE can bring more drugs to market more safely and efficiently
- 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
- Discuss the development and application of data standards, and approaches and methodologies for ensuring data quality, applicability, interoperability, privacy, security, and appropriate use throughout the medical product lifecycle
- Examine the roles and relationships of data science, data analytics, and biostatistics in the innovative application of data from all sources to bring effective therapies to patients
- Describe the current and future uses of innovative technology, including wearables and other mobile devices, in the generation and collection of patient data in support of clinical research and post-market assessment to improve patient outcomes
- Articulate the current statistical thinking that informs policy, regulation, development, review, and lifecycle management of medical products
- Discuss the application of new statistical methodologies to address complex problems in the design and conduct of research studies and to streamline the development of innovative medical products
- Identify current opportunities and challenges in the area of personalized medicine for disease treatment
- Explain key challenges and opportunities drug development for rare diseases including trial design, current regulatory pathways and frameworks, innovative technology, and how to expedite patient access
- Describe principles of benefit-risk assessment and management in the development, review and approval, and post-market phases of new medical products and therapies, including advanced therapies
- Summarize issues in clinical and post-market safety data identification and selection, collection, analysis, and reporting
- Evaluate current and emerging methods of risk communication for appropriateness for the target audience and effectiveness
- Discuss approaches and methodologies for incorporating patient perspective in the discovery, development, regulatory review, and lifecycle management of medical products to ensure that their development meets the needs and provides quality outcomes for patient health
- 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 medical product lifecycle
- Summarize effective practices to operationalize patient-centric approaches in the daily work of medical product development and lifecycle management
- 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
- Compare the current regional regulatory and public policy environment pertaining to pharmaceuticals and related products v
- Discuss the regulatory and economic factors that impact the global biopharmaceutical industry
- Evaluate the current landscape for global regulatory convergence and discuss the outcomes of harmonization efforts lead by ICH, ICMRA, WHO, and others who are leading these endeavors
- Identify legal, advertising, and marketing issues related to providing product information
- Compare the global regulatory frameworks for Advanced Therapies from preclinical research, manufacturing, clinical delivery, and licensing
- Evaluate how regulatory intelligence can be applied in global biopharmaceutical product development strategies throughout the development cycle
- Evaluate the changes of Medical Affairs functions in the medical product development landscape and its emerging role as the primary interface with external stakeholders to ensure patient access to the appropriate treatment
- Examine the challenges and opportunities in assessing medical product value and enhancing access including the roles of technological innovation and analytics, policy, and stakeholder collaboration in improving access to needed and affordable therapies
- 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
- Discuss regulations and risk-based approaches for ensuring the integrity and quality of CMC submissions, manufacturing processes and data, and quality systems in the current regulatory and technological environments, both regionally and globally
- Identify best practices to foster professional development, improve workplace dynamics, increase productivity, enhance interpersonal relationships, value diversity, and keep abreast of current hiring practices, leadership opportunities, and new technology trends
Specific learning objectives for each offering will be found on the DIA 2020 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 2020 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 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
This activity has been approved for AMA PRA Category 1 Credit(s)™.
Continuing Nursing EducationThis activity is eligible for ANCC credit, see final CNE activity announcement for specific details.
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)
Drug Information Association (DIA) is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.
Continuing Legal Education
For attorneys who would like to receive continuing legal education credits for attending DIA 2020, 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 2020 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 time-frame, 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 2020 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.