DIA 2021 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 2021 is intended to strengthen professionals’ understanding of cross-cutting concepts in biopharmaceutical development and foster collaboration across disciplines for better health outcomes.
At the conclusion of the DIA 2021 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), how RWE can inform bringing more drugs to market safely and efficiently, and the utility of RWE in promotional communications
- 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
- 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
- Discuss 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 to streamline the development of innovative medical products, and reduce bias in the healthcare system
- Explain key challenges and opportunities drug development for rare diseases 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
- 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 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 and operationalize patient-centric approaches throughout the medical product lifecycle
- 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
- 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 challenges related to providing product information and the impact of COVID-19
- Discuss the challenges associated with preclinical research and patient access for Advanced Therapies
- Evaluate how regulatory intelligence can be applied in global biopharmaceutical product development strategies throughout the development cycle
- 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
- Discuss regulatory, distribution, and technical challenges associated with N-nitrosamine detection in consumer products
- 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
- Discuss the impact of the COVID-19 pandemic on regulatory review and compliance, regulatory reliance, data collection and analysis, clinical trial design and conduct, medicines availability, and the discussion on healthcare reform
- Apply current regulatory guidance and clinical trial design strategies to increase diversity and inclusion in preclinical and clinical medical product development
- Describe approaches to inspections that drive regulatory compliance, identify process efficiency, and reduce gaps
- 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
Specific learning objectives for each offering will be found on the DIA 2021 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 2021 website with the statement CME, Pharmacy, Nursing, or PMI PDUs. CE credits are not available for the Innovation Theater presentations, Content Hubs, Community Rounds or 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 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
This 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. 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 2021, 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 2021 must login to view the live session offering in order to record their attendance at the session. Participants who do not login and attend the live sessions will not be eligible to request the available continuing education credits for session offerings. If a participant logs into multiple live offerings within the same time frame, only the last login 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 2021 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.