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Meetings held and organised by Pharmaceutical companies are an essential way of communicating and evolving scientific research, clinical development and medical education. However, there is always the danger that they can be seen as a blatant attempt to railroad Health Care Professionals into prescribing

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

products by using lavish surroundings and hospitality to influence them.

This is where the ABPI 2006 code of practice comes into its own, specifically clause 19 which deals with the arrangement and holding of HCP meetings within the Pharmaceutical industry. The key requirement being that the main purpo

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

Examples of combination products may in

se of the meeting should be its content and any hospitality offered during these meetings should not only be secondary but in fact no more than basic subsistence.

How can we work out what would and would not be acceptable? In answering this question, you would need to consider all aspects of the meeting

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

from the venue, timings, hospitality, content (including speakers) and all associated materials ie handouts, stand material and invitations and equally as important, the costs. All of these elements factor in how the end product, the meeting, will be perceived. This is how it would be deemed acceptable o

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

r not, the overall impression given from combining all of these elements. Therefore, one of the requirements of the code is that all Pharmaceutical companies have a specific policy dealing with meetings and hospitality. This must be adhered to otherwise companies can find themselves in breach of the code

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

Combination pro

which can ultimately lead to heavy sanctions against the offending company.

What sort of meetings are acceptable? In simple terms, educational meetings. This however does not rule out promotional meetings as these can be just as educational as non-promotional meetings. Either way, the educational conte

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

t of the meeting must be the primary purpose of the meeting.

To achieve the right balance between educational content and hospitality the following must be considered. Timings- Does the length of the meeting justify the hospitality offered? For example, a meeting lasting one hour in the afternoon does n

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

ot warrant an elaborate 3 course dinner and overnight accommodation, however if the meeting commenced at 12 noon and ran till 6pm and extended until the following morning, then this level of hospitality could be justified.

Costs/Quality- Is the cost and quality of the hospitality in accordance with the

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

level of the meeting? For example, a good quality venue with 3 course dinner could be booked for a meeting featuring an international speaker however would not be justifiable for a local GP speaker meeting as this would be more appropriately hosted in a conference centre.

Arrangements- Have the arrangem

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

nts been made to be suit the educational content of the meeting? For example, a talk over dinner suggests that the educational content comes secondary to the food, whereas a short meeting with just simple refreshments would indicate that the education is why people are attending.

Advertising Emphasis- D

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

oes the advertisement of the meeting ‘sell' the content or the venue/hospitality? For example, if the meeting is billed on the invitations as a ‘Gala Dinner' or being held at a ‘Luxury and Renowned Venue' this would be seen as luring the attendees on the hospitality or the quality of the venue. The meeti

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

Following aspects would a

ng must be advertised with the educational content being its primary ‘selling' point.

Venue- Is the venue appropriate to the purpose of the meeting? The meeting content should be planned first and only then a venue should be sourced to fit in with that content. Never should a venue be hired and the meet

dd to the challenges in developing combination products:

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

ng content be edited to fit to that specific venue. The venue must be professional and offer privacy for the duration of the educational content of the meeting. Nightclubs and Casinos are a big no-no.

Sporting venues and Spas should be avoided unless there really is no alternative venue to host the meet

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

ing. Any sporting venue that is used should have no fixtures immediately before, during or after the meeting. Location of the venue is also important. For example, it would not be acceptable to hold a local GP speaker meeting from the midlands in central Scotland as this would mean unnecessary travelling

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

, accommodation, expense and would be perceived as the venue being the main attraction for the meeting allowing the attendees a mini-break on the back of the meeting.

Activities- Which activities are acceptable during the meeting? Any activity offered must be professional. Activities can only be offered

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

if they relate to the main educational purpose of the meeting. Any activity which is mainly for entertainment value should not be included. For example, a round of golf, Spa treatments, wine tasting. These activities are unprofessional and therefore unacceptable in accordance with the code.

Materials- W

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

Professional from academic institutions, pharmaceutical industries, health care indust

hich materials can be used? All meetings should ideally be documented by at least an invitation or a letter confirming arrangements. All materials used must comply with the relevant sections of the code which also includes materials produced by third parties as the Pharmaceutical companies have overall c

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

ompliance responsibility. Sponsorship must be clearly stated on all relating material whether the meeting is promotional or not. All materials used must show that the meeting is in accordance to the code. For example, invitations/stands must not give the wrong impression of the meeting content.

There ar

.

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

many factors which could potentially lead to a breach of the code in booking a meeting for HCP's. Some Pharmaceutical companies are seeking help in this area by using venue sourcing companies who have been certified by an industry consultant and have in-depth knowledge of what is and not acceptable unde

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

Companies that provide selfless information through particip

r the ABPI 2006 code of compliance. This is proving to be of great use to them as although it does not remove their ultimate responsibility, it acts as a further safe guard in the need to comply.

In summary, perception is key. Put yourself in the position of an outside observer, how would it look to you

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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It is very important to have right office furniture, like computer desks, in the office. They not only help in the right seating arrangement and benefit of employees, but also create more space and lends a touch of professionalism.

Age-old traditions cause us to develop the most deeply ingrained habits. Even when conditions change so that these traditions are harmful, most people will keep following the traditions anyway. In this article, you find out how to identify where traditions are harmful and how to establish helpful new traditions that reinforce helpful directions.

You fill up your mug, jump in your car and head onto the dreaded commute of the day. Once you get to work chaos and more chaos surround you. Those half-an-hour breaks really don't cut it anymore. By the time you get home late into the evening you really don't have much time for anything but eating and sleeping which seems to keep adding to your waistline like your boss adds to your in box.

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