Continuing-Education
The DIA 2015 51st Annual Meeting is the premier event designed for individuals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related medical products. The Annual Meeting is intended to strengthen professionals’ understanding of the value of cross-discipline integration and to foster innovation for better health outcomes.
LEARNING OBJECTIVES
At the conclusion of the DIA 2015 51st Annual Meeting, participants should be able to:
TRACK 01: CLINICAL OPERATIONS
- Identify the important current clinical trial issues and how they can be addressed with innovative solutions
- Discuss methods of reducing costs while maintaining quality in the management of clinical trials using new technologies and efficient best practices
- Describe how to ensure ethical and safe treatment of subjects in the modern trial arena
PROJECT MANAGEMENT
- Identify and describe product development/project management practices and project related finance practices used in the industry and project management practices within regulatory agencies
- Discuss new project management practices and systems used in global product development
PORTFOLIO MANAGEMENT
- Identify and describe 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
STRATEGIC PLANNING
- 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, co-development partners, and other organizations
TRACK 04: PRECLINICAL AND TRANSLATIONAL DEVELOPMENT / EARLY PHASE CLINICAL DEVELOPMENT
- Explain some of the latest preclinical technologies and approaches for assessing the safety of pharmaceutical products
- 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
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 LIAISONS
- Identify opportunities to collaborate and meet the expectations of global regulatory authorities, health care professionals, patients, payers, and other customers
- Discuss successful communication channels across Medical Writing, Medical Communications, and Medical Science Liaisons
TRACK 07: TECHNOLOGY/DATA/RECORDS AND SUBMISSIONS
- Discuss best practices for the use of standards, technologies and processes in clinical trials
- Describe novel uses of existing/emerging technologies and processes
- Identify how technical and procedural innovations transform the clinical trial life cycle
TRACK 08: REGULATORY AFFAIRS
- Discuss the latest global regulatory trends and developments that impact the industry, health authorities and other stakeholders
TRACK 09: MEDICAL DEVICES, IN VITRO DIAGNOSTICS, AND COMBINATION PRODUCTS
- Discuss ways to further enhance the abilities of drug companies to meet the regulatory challenges created by innovative drug delivery, companion diagnostics and personalized medicine
TRACK 10: PUBLIC POLICY/HEALTH CARE COMPLIANCE / LAW
- Discuss implications and recommendations raised in current topics in health care compliance, public policy and law
TRACK 11: INNOVATIVE APPROACHES TO ENSURING QUALITY IN CLINICAL TRIALS AND COMPLIANCE TO GOOD CLINICAL PRACTICE (GCP)
- 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 on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
TRACK 13: COMPARATIVE EFFECTIVENESS RESEARCH/GLOBAL HEALTH OUTCOMES AND ECONOMICS
- Describe current issues in measuring and communicating the medical need, health impact, and economic value associated with medical interventions
- Evaluate treatment heterogeneity and CER (methods and applications)
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
- Discuss current information on statistical solutions to issues associated with the evidence and regulatory review of drugs, diagnostics/devices, and biologics
- Examine the role statistical professionals have in raising awareness and providing information in an continuously evolving environment
- Discuss the cross-functional exchange of ideas and problem-solving for statisticians and other stakeholders
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
- Identify the unique challenges, opportunities, and strategies that will help to shape a better future for the successful discovery and development of orphan drugs and novel treatments for rare diseases
- Examine the role of basic, translational, and clinical researchers, drug, device and diagnostics companies, governmental agencies, patient advocacy organizations and patients in novel therapy development
- Recognize the impact of rare/orphan diseases on patient well-being and health care systems
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: LATE-BREAKING TOPICS
- Discuss late breaking hot topics in the pharmaceutical, biotechnology and/or medical device industry
Select preconference tutorials and program offerings (including sessions, forums, workshops, symposia, TURBO offerings) may be approved for AMA PRA Category 1 Credits™, pharmacy or nursing contact hours, or Project Management Institute (PMI) professional development units (PDUs). Continuing education credit information will be clearly identified in the final program with the statement of CME, Pharmacy, Nursing, or PMI PDUs. IACET continuing education units (CEUs) are offered for all program offerings and preconference tutorials. Continuing education credits are NOT AVAILABLE for the Opening Plenary Session on Monday afternoon, Student or Professional Poster Sessions, Innovation Theater, or White Paper Presentations. Learning objectives for each program offering (and preconference tutorial, if applicable) will be shown in all meeting rooms.
ACCREDITATION AND CREDIT DESIGNATION STATEMENTS
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.
Credit Designation
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)
DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Participants can earn up to 24.5 contact hours or continuing education units (CEUs) for participating in the Annual Meeting program offerings and preconference tutorials.
ACPE Credit Requests MUST BE SUBMITTED BY WEDNESDAY, JULY 29, 2015
DIA is required by the ACPE to report pharmacy-requested CEUs through the CPE Monitor. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity (by Wednesday, July 29, 2015). If ACPE credit requests are not submitted within date noted above, the ACPE credit request will not be processed 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 ID, 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)
DIA has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI).
Participants may receive up to 10 professional development units (PDUs) for attending the Annual Meeting program offerings and preconference tutorial. PMI #2166-000165
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).
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 up to 3.1 CEUs for this program.
CE CREDIT ALLOCATION
PRECONFERENCE TUTORIALS – JUNE 14
Half Day Preconference Tutorials:
- 8:30 AM–12:00 PM: Up to: CME 3.25 AMA PRA Category 1 Credits™; IACET .3 CEUs; Nursing 3.25 contact hours; Pharmacy 3.25 contact hours or .325 CEUs; 3.25 PMI PDUs
- 1:00 PM–4:30 PM: Up to: CME 3.25 AMA PRA Category 1 Credits™; IACET .3 CEUs; Nursing 3.25 contact hours; Pharmacy 3.25 contact hours or .325 CEUs
Full Day Preconference Tutorials:
- 9:00 AM–5:00 PM: Up to: CME 6.5 AMA PRA Category 1 Credits™; IACET .7 CEUs; Nursing 6.5 contact hours; Pharmacy 6.5 contact hours or .65 CEUs
ANNUAL MEETING PROGRAM OFFERINGS – JUNE 16-19
Up to CME 18 AMA PRA Category 1 Credits™; 2.4 IACET CEUs (.2 IACET CEUs are offered for a 1.5 hour program offering and .1 IACET CEU is offered for a 1 hour TURBO offering); Nursing 18 contact hours; Pharmacy 18 contact hours or 1.8 CEUs; 10 PMI PDUs
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, DIA’s Certificate Program units will be available for DIA 2015 51st Annual Meeting preconference 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.DIAGlobal.org/certificateprograms.
Participants will be able to download a statement of credit upon successful submission of the credit request. Complete details and instructions for accessing CE credit will be included in the final program.
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 in the activity materials.
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.
View 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.
| Name | Credit Type | Max Credits | CEU |
| # 32: Influencing Culture, Avoiding Bureaucracy | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #20: The Sunshine Act: Understanding the Essentia | Credit TypeCME | Max Credits3.25 | CEU0.000 |
| #20: The Sunshine Act: Understanding the Essentia | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #20: The Sunshine Act: Understanding the Essentia | Credit TypeRN | Max Credits3.25 | CEU0.000 |
| #21: Leadership: How to Organize and Lead People | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #21: Leadership: How to Organize and Lead People | Credit TypePMI | Max Credits3.25 | CEU0.000 |
| #22: Successful Drug Development: Best Practices | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #23: How to Prepare for an FDA Inspection | Credit TypeCME | Max Credits3.25 | CEU0.000 |
| #23: How to Prepare for an FDA Inspection | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #23: How to Prepare for an FDA Inspection | Credit TypeRN | Max Credits3.25 | CEU0.000 |
| #24: Pharmacogenomics and Companion Diagnostics | Credit TypeACPE | Max Credits3.25 | CEU0.325 |
| #24: Pharmacogenomics and Companion Diagnostics | Credit TypeCME | Max Credits3.25 | CEU0.000 |
| #24: Pharmacogenomics and Companion Diagnostics | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #24: Pharmacogenomics and Companion Diagnostics | Credit TypeRN | Max Credits3.25 | CEU0.000 |
| #25: Signal Detection: Identifying and Managing Sa | Credit TypeACPE | Max Credits3.25 | CEU0.325 |
| #25: Signal Detection: Identifying and Managing Sa | Credit TypeCME | Max Credits3.25 | CEU0.000 |
| #25: Signal Detection: Identifying and Managing Sa | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #25: Signal Detection: Identifying and Managing Sa | Credit TypeRN | Max Credits3.25 | CEU0.000 |
| #30: Japan Regulatory Environment: Overview | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #31: Preparing for a US FDA Advisory Committee Me | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #34: Preparation of Risk Evaluation and Mitigatio | Credit TypeRN | Max Credits3.25 | CEU0.000 |
| #34: Preparation of Risk Evaluation and Mitigatio | Credit TypeACPE | Max Credits3.25 | CEU0.325 |
| #34: Preparation of Risk Evaluation and Mitigatio | Credit TypeCME | Max Credits3.25 | CEU0.000 |
| #34: Preparation of Risk Evaluation and Mitigatio | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #35: Ethical Issues in Clinical Trials | Credit TypeCME | Max Credits3.25 | CEU0.000 |
| #35: Ethical Issues in Clinical Trials | Credit TypeIACET | Max Credits3.25 | CEU0.300 |
| #35: Ethical Issues in Clinical Trials | Credit TypeRN | Max Credits3.25 | CEU0.000 |
| #40: Analysis of Safety Data from Clinical Trials | Credit TypeACPE | Max Credits6.50 | CEU0.650 |
| #40: Analysis of Safety Data from Clinical Trials | Credit TypeCME | Max Credits6.50 | CEU0.000 |
| #40: Analysis of Safety Data from Clinical Trials | Credit TypeIACET | Max Credits6.50 | CEU0.700 |
| #40: Analysis of Safety Data from Clinical Trials | Credit TypeRN | Max Credits6.50 | CEU0.000 |
| #41: Quality Oversight of CROs-Clinical Vendors | Credit TypeIACET | Max Credits6.50 | CEU0.700 |
| #42: Fundamentals of ANDA Submissions | Credit TypeCME | Max Credits6.50 | CEU0.000 |
| #42: Fundamentals of ANDA Submissions | Credit TypeIACET | Max Credits6.50 | CEU0.700 |
| #42: Fundamentals of ANDA Submissions | Credit TypeRN | Max Credits6.50 | CEU0.000 |
| #43: Clinical Statistics for Nonstatisticians | Credit TypeACPE | Max Credits6.50 | CEU0.650 |
| #43: Clinical Statistics for Nonstatisticians | Credit TypeCME | Max Credits6.50 | CEU0.000 |
| #43: Clinical Statistics for Nonstatisticians | Credit TypeIACET | Max Credits6.50 | CEU0.700 |
| #43: Clinical Statistics for Nonstatisticians | Credit TypeRN | Max Credits6.50 | CEU0.000 |
| #44: Risk Management and Safety Communication | Credit TypeACPE | Max Credits6.50 | CEU0.650 |
| #44: Risk Management and Safety Communication | Credit TypeCME | Max Credits6.50 | CEU0.000 |
| #44: Risk Management and Safety Communication | Credit TypeIACET | Max Credits6.50 | CEU0.700 |
| #44: Risk Management and Safety Communication | Credit TypeRN | Max Credits6.50 | CEU0.000 |
| #45: The Good Pharmacovigilance Practices in the | Credit TypeRN | Max Credits6.50 | CEU0.000 |
| #45: The Good Pharmacovigilance Practices in the | Credit TypeCME | Max Credits6.50 | CEU0.000 |
| #45: The Good Pharmacovigilance Practices in the | Credit TypeIACET | Max Credits6.50 | CEU0.700 |
| DIA 2015 51st Annual Meeting: Develop. Innovate. | Credit TypeACPE | Max Credits18.00 | CEU1.800 |
| DIA 2015 51st Annual Meeting: Develop. Innovate. | Credit TypeCME | Max Credits18.00 | CEU0.000 |
| DIA 2015 51st Annual Meeting: Develop. Innovate. | Credit TypeIACET | Max Credits24.00 | CEU2.400 |
| DIA 2015 51st Annual Meeting: Develop. Innovate. | Credit TypePMI | Max Credits10.00 | CEU0.000 |
| DIA 2015 51st Annual Meeting: Develop. Innovate. | Credit TypeRN | Max Credits18.00 | CEU0.000 |
Statement of Credit:
If you would like to receive a statement of credit, you must attend the tutorial, scan your name badge, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diaglobal.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” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on June 23, 2015.Have an account?