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Continuing Education

DIA 2023 brings together key thought leaders and innovators from industry, academia, regulatory and government agencies, health, patient, and philanthropic organizations from around the globe and across all disciplines involved in the discovery, development, and lifecycle management of healthcare products. DIA 2023 is intended to strengthen professionals’ understanding of cross-cutting concepts in biopharmaceutical development and foster collaboration across disciplines for better health outcomes.

Learning Objectives:

At the conclusion of the DIA 2023 Global Annual Meeting, participants should be able to:

Discuss priorities, plans, and updates from global regulatory health authorities and organizations
Compare the current regional regulatory and public policy environment pertaining to pharmaceuticals and related products
Evaluate the current landscape for global regulatory convergence and discuss the outcomes of harmonization efforts lead by global regulatory health authorities and organizations
Discuss the continued global impact of the COVID-19 pandemic on regulatory review and compliance, regulatory reliance, data collection and analysis, clinical trial design and conduct, supply chain challenges, and healthcare reform
Discuss the regulatory and economic factors that impact the global biopharmaceutical industry
Discuss the development and application of data standards, and approaches and methodologies for ensuring data quality, applicability, interoperability, and appropriate use throughout the medical product lifecycle
Discuss the changing data landscape with a focus on use of real-world data/real-world evidence (RWD/RWE) for use in regulatory assessments decision-making
Describe the current and future uses of innovative technology in the generation and collection of patient data in support of clinical research and post-market assessment to improve patient outcomes
Describe current issues and approaches in designing and implementing clinical trials, including patient recruitment and integration, site selection, and management of multi-regional clinical trials
Discuss the current statistical thinking that informs policy, regulation, development, review, and lifecycle management of medical products
Identify common ethical issues currently facing researchers, how different stakeholder communities may differ in their stances on these issues; and evaluate proposed responses on the part of sponsors
Examine how to develop cross functional collaborations within companies and engage with regulators to achieve diversity goals and identify concrete strategies to achieve these goals through community partnerships, training, and other proactive initiatives
Explain key challenges and opportunities drug development for rare diseases and special populations including trial design, use of real-world data, risk evaluation and management, 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 and the utility of including the patient voice
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
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
Summarize issues in clinical and post-market safety data identification and selection, collection, analysis, and reporting
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 best practices and emerging trends for delivering medical and product information across internal and external customers and collaborators
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
Create effective project management strategies to maximize productivity in a drug development partnership, minimize risk, and utilize analytics and artificial intelligence to enhance decision-making
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

View instructions for requesting CE credits

Specific learning objectives for each offering can be found on the DIA 2023 website under the program in the coming months.

Select short courses and program offerings (including sessions, forums, and or nursing contact hours, Project Management Institute (PMI) professionaldevelopment units (PDUs), or International Association for ContinuingEducation and Training (IACET) continuing education units (CEUs).Continuing education credit information will be clearly identified on the DIA2023 website with the statement CME, Pharmacy, Nursing, or PMI PDUs. CEcredits are not available for the Innovation Theater presentations, ContentHubs, Community Rounds, Sponsored events.

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 21.5 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 21.5 contact hours. California Board of Registered Nursing, Provider Number 13485, approved for 21.5 contact hours.

View instructions for requesting CE credits

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. This program is designated for up to 21.5 contact hours or 2.15 continuing education units (CEU’s).
ACPE Credit Requests MUST BE SUBMITTED by Friday, August 11, 2023. 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 Friday August 11, 2023, 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.
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).
Participants may receive up to 7 professional development units (PDUs) for attending the Annual Meeting program offerings. All approved DIA designated PMI numbers for approved offerings are found on the DIA 2023 Global Annual Meeting website on each designated offering description.

The PMI Registered Education Provider logo is a registered mark of the Project Management Institute, Inc.
International Accreditors for Continuing Education and Training (IACET)

Drug Information Association (DIA) is accredited by the International Accreditors for Continuing Education and Training (IACET) and offers IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Standard. IACET is recognized internationally as a standard development organization and accrediting body that promotes quality of continuing education and training.

As an IACET Accredited Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer 2.1 CEUs for this program.
Continuing Legal Education

For attorneys who would like to receive continuing legal education credits for attending DIA 2023, 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 2023 must scan their DIA name badge at each offering to record their attendance. Participants must scan their badges within 15 minutes of the start of the of the 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.

Please be sure to complete your session evaluation at the end of each day, located at: DIAglobal.org/DIA2023evals Further instructions for requesting your statement of credit will be provided in the final program.

Further instructions for requesting your statement of credit will be provided in the final program.
Disclaimer

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 faculty, planners, managers and other individuals who are in a position to control the content of this activity to disclose all their financial relationships with ineligible companies. They may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted and mitigated by PIM and DIA according to PIM policy 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 2023 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.