Strategies for Comparative Effectiveness Research for Regulatory, Compliance and Legal Professionals in Life Sciences Promotion
Apr 23 2013 11:00AM - Apr 23 2013 12:30PM | Online
This program, Strategies for Comparative Effectiveness Research for Regulatory, Compliance and Legal Professionals in Life Sciences Promotion, will help Regulatory, Compliance and Legal professionals in the Life Sciences Promotion arena understand how CER will impact their future business practices, sales & marketing oversight, and business ethics. This online course will combine background instruction into the principals of CER, current and future impact on the broader regulatory industry, along with implications for future communications, marketing, monitoring and resource planning. Real-world examples will be used to help explain changing implications of new sources of data and outcomes measures, detailing the transition to newer CER based advertising and promotional material and how to effectively incorporate these into developing corporate sales and marketing, value research, and product attribute messaging. This practical program will allow attendees to identify and assimilate current changes to long established practices, plan for upcoming regulatory transitions to the new CER standards, and methods to effectively include these changes into future corporate product marketing and research planning.
Purchase two of the following online courses in one transaction and save 10%. Purchase all three in one transaction and save 20%. Discount will be reflected in the final step of the checkout process. (Special pricing valid for online registrations by individuals and groups. Does not apply to already discounted fees.)
- How to evaluate CER information into minimum FDA and scientific hypothesis standards
- How to appropriately apply CER outcomes data & messages into advertising & promotional material
- Methods to ensure “Good Clinical Trial” design & implications into future product claims
- Identify if CER studies meet the rigor for Phase II/III trial design, label extension and claims data
- Measure the relative validity of both qualitative and quantitative data
- Apply appropriate comparisons of non-clinical trial outcomes such as: retrospective claims, single arm, case studies and observational data sets
Who Should Attend
- Regulatory, legal affairs, risk manager professionals in life sciences pomotions
- Compliance and communication personnel in life sciences pomotions
- Sales & marketing training
- Business development, marketing & promotions
- Quality and safety outcomes research professionals
- Clinical professionals & operations oversight, data managers
- Medical writers, medical affairs & biostatisticians
At the conclusion of this activity, participants should be able to:
- State what CER data and methods are included and excluded from regulatory standards
- Illustrate which FDA Guidelines have been changed and upheld to address CER information
- Describe appropriate product marketing and messaging use for outcomes and any required disclosures
- Identify areas of oversight for field Sales and Marketing personnel, scientific and publication expectations vs. prior standards
- Identify and explain key personnel, resources and expertise needed to meet CER requirements
- Recognize federal and state regulatory agencies and requirements to meet CER usage standards
Register for multiple courses in this CER series and save up to 20%!
for minimum system requirements.
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.
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 .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 1 Elective Units
For more information go to www.diahome.org/certificateprograms
Continuing education credits are available to learners who participate in the live online training course. Continuing education credits are not available for participation in the archived version of the online training course.
|Strategies for Comparative Effectiveness Research
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must participate in the live online course and complete the on-line credit request process through My Transcript at www.diahome.org. 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 two weeks after the last day of the activity.
To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE
- Government (Full Time) Individual
- Charitable Nonprofit/Academia Individual
- Group Site
- Member Individual
- NonMember Individual
A Series Discount is Available
Save up to 10% when purchasing two online training courses in this series and 20% by purchasing all three courses in the series. You must register online in one transaction to receive the discount. (Special pricing valid for online registrations by individuals and groups. Does not apply to already discounted fees.)
Group Site Discount:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.
*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.
Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: 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.