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You know it's time, you feel it, you've been lazy for so long, you dream about something else, you just have to leave. You made your calculations and you felt that it's the right time to do it, maybe you found a better job, maybe you didn't, but you can't stay anymore: staying is hurting you. Finally you decide to resign, but little did you

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

know that your resignation day is the most important day in your current job. Granted, resignation is not usually an easy thing to do, but doing it properly will maintain a good view about you among your workmates and your bosses forever. In theory, resigning is very easy, you just have to submit that resignation paper, and you're free as a

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

Examples of combination products may in

bird. However, if you were a good resource, your responsible will feel cheated, and will act a bit on the offensive side. He/she might also try to tempt you with more money and/or a higher position. On the other hand, if you were a bad resource, you would feel very tempted to point fingers, to talk about how bad you were treated, and of cou

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

se, to jog memories of old stories.

Resigning professionally, on the other hand, requires carefulness.

For starters, keep the resignation decision to yourself until you make it official. Though it's very tempting to tell your favorite workmate about that new job offer that you had, or how you're going to settle things straight with the com

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

pany both of you always hated, you'd be placing your workmate in a situation where he/she will feel betraying the company.

Once you decide on the resignation, schedule a closed meeting with your boss, but just before that, make sure you prepare the resignation letter. The most professional resignation letter I found (and used), is the follo

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

Combination pro

wing:

Letter of Resignation

Date: [Current Date] To: [Name Of Your Boss]

Please accept this letter as my formal notice of resignation from [Name Of The Company], effective [Current Date]. The associations I've made during my employment here will truly be memorable for years to come.

I hope a one-month notice is sufficient for you to fin

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

a replacement for me. If I can help to train my replacement or tie up any loose ends, please let me know. Also note that I would like to remain associated with the company as an independent contractor in case extra resources are required.

I thank you for giving me the opportunity to work for [Name Of The Company]. I wish the company contin

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

ued success in present and future endeavors.

Sincerely,

[Your Name & Signature]

The nice thing about this resignation letter is the strong English, and that it maintains an open channel with you and the company (I would like to remain associated...). Note that depending on the region you're in, your responsibilities, and the number of yea

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

rs you spent in the company, the notice period can be anything between 1 week and 3 months. In North America, 2 weeks notice is the standard, on the other hand, in Europe and elsewhere, 1 month (and up to 3 months in some cases) is the norm.

Now in the closed meeting the first thing you have to do is to give your boss your resignation. It i

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

very critical to remain calm, even if your boss loses his/her temper. If you're really a good resource, then your boss will try his/her best to know why and to where you're leaving (never reveal such information). Your boss might also tempt you with more money and/or higher position. Keep in mind, however, that this a trap, and you have to

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

answer YES for ALL the the following questions before taking his offer:

1. Will you be able to work normally after resigning and then un-resigning? (the answer will always be no to this one)

2. Do you really think it's professional to make such an important decision and then take it back (After all, you're not 10 years old) ?

3. Are you 1

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

Following aspects would a

00% sure that they're not buying time just to find a replacement?

4. Was money and/or authority (depending on your offer) the only reason(s) you were leaving the company for?

5. Are the changes to your salary/position clear and immediate?

6. Are the changes to your salary/position really worth it?

7. Are you OK with not taking the other

dd to the challenges in developing combination products:

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

ffer that you had from another company (if available)?

8. And finally, if you answered YES to all the above (and I seriously doubt you will), will you always have to resign just to get what you want?

Be very careful with a counter offer, because simply it is always a trap. You can always take it, but you will for sure regret it.

In case y

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

ou're a bad resource, you might be tempted to point fingers. "It's all Sara's fault", "John was uncooperative", "Working under you was very stressful". Sure you will feel better for the next 5 minutes or so, but it'll make you feel stupid for the rest of your life because you simply burnt your bridges, and quite frankly, there is no gain wha

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

tsoever in doing that.

If available, discuss your resignation package. Make sure to get all your rights very calmly. You might want to kiss some hands here & there, but remember, this is for you own good.

Now that your resignation is official, you still have the notice period where you have to spend time in the company under totally differ

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

nt conditions. Usually this period is hell. You will feel you are being treated differently (in the negative sense), you will have more restrictions on your PC than you can shake a stick at, and most of your workmates will avoid having conversations with you (they don't want to be suspected as your accomplices, after all). Normally, you won'

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

Professional from academic institutions, pharmaceutical industries, health care indust

t have to be really productive during this period, all you usually have to do is to probably sit down with the person who's gonna take over your responsibilities explaining to him/her what to do, and that's about it.

On your last day, it is very important to have little chats with all the people that you think you hurt and/or had misunderst

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

anding with during your stay at the company. Apologizing to a person always makes both parties feel great. You can turn a fierce enemy into a helpful friend in about 5 minutes with this strategy. Once that day ends, say bye to all your workmates and your bosses in a very nice and short way, and prepare yourself to face the world again.

Alwa

.

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

s remember, do not burn bridges; you will never know when you're going to need these people again. I remember this job I resigned from, where the owner of the company told me while I'm leaving: "So Fadi, good-bye, and hopefully we will meet again", "We will meet again", I replied, "after all, it is a small world". He looked at me with a smil

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

Companies that provide selfless information through particip

e on his face and replied: "It IS a small world!". Few years later I met him in Amsterdam where he gave me a much better job offer than the one I originally had. Although I didn't take the offer, I was wondering if he would have given me that offer had I burnt my bridges when leaving. I was also wondering how very small the world is becoming

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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