The DIA 2013 49th Annual Meeting is the premier event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products.
At the conclusion of the DIA 2013 49th Annual Meeting, participants should be able to:
TRACK 01: CLINICAL OPERATIONS
- Discuss advancing clinical operation innovation through collaboration and process optimization
- Apply operational execution through effective budget management and patient recruitment across different patient groups
- Identify innovative considerations for protocol optimization and risk-based monitoring
TRACK 02: PROJECT/PORTFOLIO MANAGEMENT AND STRATEGIC PLANNING
- Describe product management, and project-related finance practices used in the product development industry, and project management practices within regulatory agencies
- Discuss new project management practices and systems used in global product development
- Examine product development portfolio management practices, portfolio asset strategy decision making methods, and associated tools
- Discuss new portfolio asset strategy decision-making, management, and portfolio/product prioritization/optimization practices
- Identify complexities of clinical trial design
- Describe approaches to quality design of clinical trials and to building quality risk management into clinical trials from both sponsor and regulatory agency perspectives
- Discuss project and portfolio management practices for strategic planning
TRACK 03: INNOVATIVE PARTNERING MODELS AND OUTSOURCING STRATEGIES
- Identify innovative partnering models and unique outsourcing strategies that are shaping the way in which pharmaceutical and biotechnology companies work with contract research organizations (CROs) and other service providers, academia, codevelopment partners, and other organizations
TRACK 04: NONCLINICAL AND TRANSLATIONAL DEVELOPMENT/EARLY PHASE CLINICAL DEVELOPMENT
- Discuss recent advances in coping with particularly challenging issues that arise in the early phases of novel pharmaceutical development
- Describe current strategies for designing successful early clinical pharmacology and clinical trials
- Identify information needed to facilitate successful early interactions between regulatory agencies and other stakeholders such as key opinion leaders and patient advocacy groups
- Explain some of the latest nonclinical technologies and approaches for assessing the safety of pharmaceutical products
TRACK 05: REGULATION OF PRODUCT ADVERTISING AND MARKETING IN AN EVER-CHANGING WORLD
- Discuss the current regulatory landscape related to drug advertising and promotion
TRACK 06: MEDICAL COMMUNICATION, MEDICAL WRITING, AND MEDICAL SCIENCE LIAISON
- Identify opportunities to collaborate and meet the expectations of multiple global regulatory authorities, patients, payers, and other customers
TRACK 07: PROCESSES AND TECHNOLOGIES FOR CLINICAL RESEARCH
- Discuss best practices for technologies and processes in clinical research
- Describe novel uses of existing/emerging technologies and processes
- Identify how technical and procedural innovations transform the clinical trials life cycle
TRACK 08: REGULATORY AFFAIRS AND SUBMISSIONS
- Discuss the latest global regulatory trends and developments that impact the industry
TRACK 09: MEDICAL DEVICES, IN VITRO DIAGNOSTICS, AND COMBINATION PRODUCTS
- Discuss updates on changing regulatory practices
TRACK 10: PUBLIC POLICY/HEALTH CARE COMPLIANCE/LAW
- Discuss implications of and recommendations raised in current topics in health care compliance, public policy, and regulatory law
TRACK 11: INNOVATIVE APPROACHES TO ENSURING COMPLIANCE WITH GOOD CLINICAL PRACTICE (GCP) AND QUALITY ASSURANCE (QA)
- Describe innovative approaches being used to manage GCP compliance and ensure quality in the development of new therapeutics in a changing international regulatory landscape
TRACK 12: PHARMACEUTICAL QUALITY
- Explain how to apply fundamental and advanced scientific and regulatory approaches to current and emerging pharmaceutical quality issues, including a strong emphasis on global harmonization efforts within and outside the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
TRACK 13: HEALTH ECONOMICS AND OUTCOMES (HEO)/COMPARATIVE EFFECTIVENESS RESEARCH (CER)/HEALTH TECHNOLOGY ASSESSMENT (HTA)
- Describe current issues in measuring and communicating the medical need, health impact, and economic value associated with medical products
TRACK 14: CLINICAL SAFETY AND PHARMACOVIGILANCE
- Discuss a broad array of concepts and tools (traditional and new) that support participants’ pursuit of excellence in patient safety, for both investigational and marketed health care products
TRACK 15: STATISTICAL SCIENCE AND QUANTITATIVE THINKING
- Identify innovative statistical solutions to issues associated with the evidence and regulatory review of drugs, diagnostics/devices, and biologics
- Describe relevant application of statistical science and quantitative thinking to the development of new therapeutic biologics, drugs, and diagnostics/devices
TRACK 16: PROFESSIONAL DEVELOPMENT
- Discuss ways to foster advancing therapeutic innovation and regulatory science through professional development and educational efforts
TRACK 17: RARE/ORPHAN DISEASES
- Discuss the unique challenges in translating/developing novel treatments for rare/neglected diseases, particularly the importance of knowledge of natural disease progression and patient registries
- Recognize the potential contributions of patients and patient advocacy organizations to effective and efficient novel therapy development
TRACK 18: GLOBAL REGULATORY
- Discuss key initiatives, changes, and challenges of various global regulatory agencies with the review of drugs, diagnostics/devices, and biologics
TRACK 19: COMMUNITIES SHOWCASE
- Discuss discipline-specific topics with a global community and share common experiences and knowledge with others in a particular field
TRACK 20: EXECUTIVE PROGRAM
- Describe the landscape for bioinnovation
- Discuss how companies across the pharmaceutical sector are transforming their R&D business models to meet current and future market demands
TRACK 21: LATE BREAKER
- Discuss late breaking hot topics in the pharmaceutical, biotechnology and/or medical devices industry
Select tutorials and program offerings (including sessions, forums, workshops, symposia) have been approved for AMA PRA Category 1 Credits™ and will also offer pharmacy or nursing contact hours, or Project Management Institute (PMI) professional development units. Continuing education credit information will be clearly identified in the final program with the statement of CME, Pharmacy, Nursing, or PMI. IACET continuing education units (CEUs) are offered for all program offerings and tutorials. Continuing education credits are not available for the plenary session on Monday morning, innovation theater, or white paper presentations. Learning objectives for each program offering (and tutorial, if applicable) will be shown in all meeting rooms.
Accreditation and Credit Designation
Accreditation Council for Continuing Medical Education (ACCME)
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and the Drug Information Association. PIM is accredited by the ACCME to provide continuing medical education for physicians.
The Postgraduate Institute for Medicine designates this live activity for a maximum of 24.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Accreditation Council for Pharmacy Education (ACPE)
The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Participants may earn up to 24.5 contact hours or 2.45 continuing education units (CEUs) for participating in the DIA 2013 49th Annual Meeting program offerings and tutorials.
Update for all ACPE Credit Requests
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. 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 www.cpemonitor.net.
American Nurses Credentialing Center (ANCC)
This educational activity for 24.5 contact hours is provided by PIM.
PIM is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
California Board of Registered Nursing
PIM is approved by the California Board of Registered Nursing, Provider Number 13485 for 24.5 contact hours.
Project Management Institute (PMI)
The Drug Information Association has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI).
Participants may receive up to 18.5 professional development units (PDUs) for attending the DIA 2013 49th Annual Meeting program offerings and tutorials.
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 has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; +1.703.506.3275.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer up to 3.1 CEUs for this program and tutorials.
Continuing Legal Education
For attorneys who would like to receive continuing legal education credits for attending DIA 2013, 49th Annual Meeting, please complete your state’s application for credit and submit accordingly.
If you require additional information to complete your application, please contact Karen.Wetzel@diahome.org for assistance.
CE CREDIT ALLOCATION
Tutorials – June 23, 2013
- (8:30 AM – 12:00 PM) Up to 3.25 AMA PRA Category 1 Credits™, or 3.25 pharmacy contact hours or .325 CEUs, or 3.25 nursing contact hours, or 3.25 PMI PDUs, or .3 IACET CEUs
- (1:00 PM – 4:30 PM) Up to 3.25 AMA PRA Category 1 Credits™, or 3.25 pharmacy contact hours or .325 CEUs, or 3.25 nursing contact hours, or .3 IACET CEUs
- (1:00 PM – 6:00 PM) Up to 4.75 AMA PRA Category 1 Credits™ or .5 IACET CEUs
- (9:00 AM – 5:00 PM) Up to 6.5 AMA PRA Category 1 Credits™, or 6.5 pharmacy contact hours or .65 CEUs, or 6.5 nursing contact hours, or 6.5 PMI PDUs, or .7 IACET CEUs
- (9:00 AM – 3:45 PM) .5 IACET CEUs
Annual Meeting Program Offerings – June 24-27, 2013
Up to 18 AMA PRA Category 1 Credits™, or 18 pharmacy contact hours or .18 CEUs, or 18 nursing contact hours, or 12 PMI PDUs, or 2.4 IACET CEUs (up to 1.5 hours per program offering)
DIA Certificate Programs
Individuals enrolled in DIA Certificate Programs may receive elective units for the designated programs noted below:
- Clinical Research Certificate Program: 12 Elective Units
- Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
- Project Management Certificate Program: 8 Elective Units
- Regulatory Affairs Certificate Program: 12 Elective Units
In addition, elective units will be available for DIA 2013 49th Annual Meeting tutorials. See specific units that are available for each offering noted in preliminary program book. For more information on DIA’s Certificate Program, visit www.diahome.org/certificateprograms.
Statement of Credit
Participants who would like to receive continuing education credits for the DIA 2013 49th Annual Meeting must scan their DIA name badge at each program offering to record their attendance and complete each program offering evaluation form. Participants may scan their badges within 45 minutes after the start of each program offering. Attendees who do not scan their badges within the allotted time will not be eligible to request the available continuing education credits for that program offering.
To request a statement of credit, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” for each program offering. My Transcript will be available for all DIA 2013 49th Annual Meeting participants to request credit on Tuesday, July 2, 2013.
Keep in mind, to receive continuing education credit you must:
- Scan your DIA name badge at each program offering
- Complete an online evaluation form for each program offering you attend
- Request a statement of credit by visiting www.diahome.org
If you experience any difficulties, please contact DIA at email@example.com
Disclosure of Conflicts of Interest
Drug Information Association (DIA) and Postgraduate Institute for Medicine (PIM) requires 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 DIA and PIM for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.
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 Drug Information Association. 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.
DIA’s Grievance Policy.
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.