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Combination Products and Convergence: An Overview of Clinical Benefits, Regulatory Issues & Manufacturing Challenges

Dec 5 2013 11:00AM - Dec 5 2013 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


An estimated 30 percent of all new healthcare products under development today are combination products. Why? Because drugs, biologics and medical devices, when used alone, can only slow or stop the progression of disease or injury. In order to tackle the clinical problems of the future, these products will be combined (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s, cancer, diabetes and beyond! In fact, every area of medicine will benefit because we can potentially erase the damage of disease or injury not just stop it – that’s not the next evolutionary advance in medicine, that’s a revolutionary advance, a change in the ethos of how why approach medical problems.

Today, the best known example of a combination product is the drug-eluting stent. Other examples include companion diagnostics and antibody-drug conjugates but that’s just the beginning. What about delivering multiple drugs and biologics on a single device? And what if we apply these drugs and biologics to the device at the patient’s bedside based on that particular patient, i.e., personalized medicine? Or we use one combination product to deliver another combination product? In fact, the true scope of combination products is even broader and includes the emerging areas of therapeutic foods and consumer products as well. The possibilities are endless and the best is yet to come! The quintessential example of a combination product is what we are now doing in tissue engineering (a.k.a. regenerative medicine) and biomedical nanotechnology. During this webinar, participants will be exposed to a wide range of examples of combination products on the market, under development and on the drawing board.

Who Should Attend 

This webinar is designed for:

  • Drug Development and R&D Professionals
  • Pharmaceutical and Medical device and Diagnostics Professionals
  • Regulatory, Clinical and Other Professionals Responsible for Developing Drug/Device Combinations and Companion Diagnostics
  • Regulatory Affairs Professionals

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Define combination products
  • Identify examples of combination products on the market, under development and on the drawing board

Contact Information 

Registration Questions
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199
Melissa.Buchanan@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for 1.5 contact hours or .15 continuing education units (CEU’s). 0286-0000-13-094-L01-P; Type of Activity: Knowledge

ACPE Credit Request Update
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.

The 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 .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:
• Regulatory Affairs Certificate Program: 1 Elective Unit

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Combination Products and Convergence ACPE 1.50 0.150
Combination Products and Convergence IACET 1.50 0.200

Disclosure Policy:

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 webinar, and complete the online credit request process through My Transcript. To access My Transcript, 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” 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 Thursday, December 19, 2013.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits and Certificate Program Units are not available for participation in the archived version of the webinar.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$995.00

Member

Member Government Individual
$125.00
Member Academia Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
NonMember Academia
$175.00
NonMember Individual
$295.00
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


CANCELLATIONS
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar 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.

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