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In the new corporate environments where everyone wears more than one hat, trainers are often responsible for a myriad of duties beyond just facilitating new training classes. Their job is often that of

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

Maintenance, IT Guru, Subject Matter Expert, Coach, Instructional designer, and Copy Clerk. There is an incredible amount of work that has to happen for a training event to occur. Let’s look a little c

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

Examples of combination products may in

oser at the process.

Training starts with a new tool/ new behavior or a new policy. The training team is brought in at the development stage to work as a subject matter expert. They may be asked to do

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

Needs Analysis to identify what skills or behaviors will need to be learned or changed. They may also be engaged in the instructional design, so they need to see the project from the ground up. Traini

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

g is called upon to represent what they think the client responses or questions may be and help the developers prepare to answer those questions.

Once the focus of the training has been identified the t

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

Combination pro

ainer will often be involved in the creation of the training materials. This can consist of everything in the instructional design process, from screen shots to learning activities, to knowledge checks.

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

As the training guides are created the trainer serves as guinea pig for the materials, editor, and system tester to see if the material validates the learning. One the materials are complete the traini

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

g team is often responsible for printing, collating, binding and distributing the materials for use. They are also responsible for long term maintenance of the materials, constantly updating any changes

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

in the process.

The training team then steps into the role of liaison between departments. They discuss calendars, launch dates, business demands and space availability to help determine opportune trai

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

ing schedules. They often take on the role of communication and are responsible for any hoopla that is created around the training initiative.

The trainer is then in charge of preparing themselves and

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

he training room for the training event. They must attend Train the Trainers to make sure that they know how to deliver the material. They must take notes and practice their facilitation skills on anyt

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

Following aspects would a

hing that they may have difficulty with. The trainer will prepare the room, making sure all the systems work, testing any projectors, sound systems, computers or lights that might be needed.

If the tra

dd to the challenges in developing combination products:

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

ning event is a new computer tool or program the trainer tests access and response times in the training databank and confirms that the students will be able to log into the system and that the system mi

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

ics what will happen in the live data base.

If the training involves change management or behavioral skills, the trainer must be able to provide reasons for buy in and examples of successful implementat

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

on of the skill. In change management situations the trainer is often called on to act as proponent, counselor and communication liaison. The trainer is often the voice of the client as well as that of

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

the agent.

Once the training event is complete the trainer steps into role of coach or observer and goes back into Needs Analysis to assess the effectiveness of the training event, close skill gaps and

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

Professional from academic institutions, pharmaceutical industries, health care indust

rovide additional support to the trainees as they practice new skills or behaviors.

Trainers are often considered the point of contact to verify and validate information and are expected to be current o

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

any changes, deals, policies or information in the daily interactions of their clients.

The training team is an integral part in the ongoing growth and development of a company and it takes flexibility

.

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

intelligence, personality and the ability to plan, multitask and deliver. They are expected to stay current in training practices, build their own skills and apply new training techniques into their pr

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

Companies that provide selfless information through particip

sentations. As the world of training evolves to include e-learning, Web CT and blended learning the trainer must be able to adjust and provide value services in an ever demanding Call Center environment

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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