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The accurate and standardized collection of data plays a vital role in the success of a clinical trial. An

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

important step in electronic clinical data management (eCDM) is electronic data capture (EDC).However, th

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

success of EDC is dependent on how well-trained and knowledgeable the clinical research coordinators and

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

associates are in the use of EDC. There are many options for training on an EDC solution – printed materia

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

s, but these can quickly become out of date and the success is dependent on how the individual uses the ma

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

terial, classroom training, but this can be expensive to conduct or webcasts, which can be more cost effec

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ive to conduct, but participants can get lost in the large number of participants that webcast can have.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

What other options are out there to offer good EDC training to your attendees? eLearning, or computer-base

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

training, is a good option to incorporate into your overall training plan. It may not be best to complete

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ly replace classroom or other types of training with eLearning, but by allowing attendees to work at their

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

own pace on their own time, eLearning can be a valuable learning experience. The perfect platform to condu

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ct EDC training is an Investigator Meeting, where attendees can receive one on one attention while going t

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

rough the training process at their own pace.

eLearning solutions are more efficient and are easy to use.

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Many options are web-based, meaning they don’t require user to install anything on their own computers. T

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

is also means that the system can be accessed from any location via the internet or a CD. The content is e

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

asy to update and customized – if a change comes along, the training administer just needs to update the c

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ntent on the system. The need to print out additional content for training manuals is eliminated. eLearnin

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

g solutions also saves the results of any and all electronic test that are taking. These record can be eas

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ly access to show exacting competency and compliance with 21 CFR Code 11.

Need help setting up EDC traini

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ng at your next Investigator Meeting? Contact Designing Events at info@designingevents.com or 866-867-1933

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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A good way to cash in on your artistic and creative skills can be to establish a craft business. It may be that you had never ever thought about commencing with creating innovative and attractive crafts for earning profits secured by their sale.

Do you fear competition or is it just a fact of life? Your answer dictates what your future actions will be.

Color printing furnishes reproduction of images and text in color, which cannot be produced in monochrome printing processes. The technique is also referred to as four-color process printing when only CMYK, i.e., cyan, magenta, yellow, and black are used while printing. Six-color process printing is another method of color printing that involves addition of orange and green colors to the traditional CMYK color scheme, making possible more vibrant color combinations.

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Advice Pool - Pharmaceutical Investigator Meetings: Improve EDC Training with eLearning

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