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References - Sailing Action Process Flow Lists
Some day skipper candidates asked to see on paper the ‘process flows’ for carrying out typical tasks on a sailing yacht. This sort of approach is perhaps less intuitive than learning the logic behind the
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
required actions, but for those who think this way, it can be very reassuring to see things as logical lists.
Raising the Main Sail
Raising the Main Sail
- Remove sail ties or unzip cover
- Head boat close to w
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nd rather than dead in to wind so that boom is to one sidePosition crew ahead of mast or in cockpit Release mainsheet & kicking strap (also known as the vang or kicker) Free main
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
halyard jammer to give slack at mast so that it can be removed from the cleatClose jammer and pull up as crew if available sweat at the mast Watch for jams e.g. batons catching in the la
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
yjack linesTension so that horizontal creases disappear Release the topping lift Tension the main sheet to get top batten parallel to the boom Tension the kicker
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Raising the Genoa
- Check the position of the jib/genoa car and cleat the line
- Let out the furling line under control around a winch
- Take the leeward jib/genoa sheet around a winch
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
3 turns and pull out the sailWinch in to correct position to get telltales flying evenly on both sides Gybing
- Helmsman looks around and calls 'stand by to gybe'
- Release
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
gybe preventerSheet in the mainsail Prepare headsail sheets When the main is in the middle, the helmsman turns the wheel and calls 'gybing' Main & jib flip across
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Ease out mainsheetRe-rig preventer on the other side Tacking
- Helsman looks around and calls 'ready about'
- Crew prepares sheets - windward take 3 turns, leeward take she
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
t out of self-tailerCrew call 'ready', helm calls 'helms to lee' or 'tacking' Release leeward sheet quickly as sail starts to back Pull in new sheet Crew change sides of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
he boatReefing
- Send crew to mast (harness if rough)
- Head boat on to close hauled course to keep sailing under headsail
- Ease the kicker
- Ease the mainsheet to lea
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ve mainsail flappingPull up topping lift if needed (where no rigid vang) Take main halyard around a winch, lift jammer and ease out Mastman pulls sail down and puts reefing cring
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
e over the rams hornClose jammer and re-tension main halyard checking for sailcloth not getting caught Pull in, then winch tight, the reefing pennant line, checking for sailcloth not get
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ing caughtEase the topping lift Pull in the mainsheet to start sailing again Pull in the kicking strap Take up the slack in the other reefing pennants and tidy all lines<
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
li>Tie loose sail to boom with sail ties and reef notes Man overboard under engine
- Shout 'man overboard' and keep someone spotting at all times
- Tack immediately and leave he
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
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
dsail backedThrow danbuoy and horseshoe lifebelt Press MOB button on GPS to provide a datum Sheet in mainsail Furl away headsail Check for lines in the water
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
li>Start engine and return to casualty from downwind, MOB to leewardPick up using stern ladder if calm or by shrouds using lasso, spare halyard or handy billy from the boom Keep casualty
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
warm in dry clothes and head for nearest portHeaving to
- Reduce size of the headsail to jib or smaller
- From close reach, tack without adjusting the sheets
- As boat turns
.
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
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
n to new tack, slowly turn wheel back until full lock to windLock steering and put on the kettle Saling goose winged with a poled out headsail
- Rig inboard end of pole
- R
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
g topping lift and downhall (foreguy) to the spinnaker pole bridleClip windward sheet in to jaws of pole Raise pole to horizontal Pull back on jib sheet to fill the sail
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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