Planning an event is stressful, whether you’re an experienced event planner or doing it for the first time. That adrenaline, however, is paramount to the successful running of an event: it’s what you need to spin all those plates and execute the actual event. Read on for this simple and short guide to keeping your cool whilst embracing the pressure to help get your event off the ground.

Checklist and Timeline Planning

Before you do anything, make a checklist. This checklist can include everything from the vital (venue) to the seemingly trivial (napkins). Once you have your checklist, split it into things to buy and things to do. Then draw up a timeline of events, with deadlines for each item on the list. Refer back to this list on a daily basis to ensure that nothing has been left behind. Leave space to add new things into the list too. Budget at this point too, and try to factor in a 10% contingency overall.

Venue

The venue should be the first thing you book, especially if your event is a wedding, as you are often more limited on dates, season and days of the week.

Think carefully when picking a venue, as it needs to tick a lot of boxes. Check whether your venue has enough covered areas. Would you need a marquee too? If you need marquee hire in Kent or London, it’s worth organising this early on. Established firms such as http://www.2intents.co.uk provide marquee hire in Kent.

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Staying Cool

Accept the adrenaline as part of the job and work with it; you need to feel a bit pressured to get the event actually off the ground, but that doesn’t mean you shouldn’t also stay calm. Keep your cool by sticking to your checklist, the timeline and the budget. Hold regular meetings to ensure everything is going to plan.

Evaluate and Reflect

Take the time to listen to feedback from those that attended, as well as those that were part of the planning. Hold an evaluation meeting as soon as possible after the event and reflect on everything that’s said.

Staying cool in the face of event planning is essential, but never stay quite so cool that you miss vital things. Planning is key to successful event planning, as is evaluation.

Clinical trials need to be carried out by a professional and experienced team of researchers. One of the main roles belongs to the clinical research associate (CRA) is to help test new treatments such as drugs for their safety, effectiveness and health benefits. More often than not, a clinical research associate is employed by a pharmaceutical company via organisations such as G and L Scientific, to get involved with various stages of the clinical trial. When searching for ideal clinical research associates, it can be difficult to know what to look for, which is why we have included the most important qualities and skills every CRA should have.

Trained in ICH/GCP Guidelines

Proper training is required in both ICH and GCP guidelines. In top of this, additional training is necessary in the Code of Federal Regulations, EU Clinical Trial Directive and sufficient knowledge in the associated local regulations.

Excellent Development and Protocol Writing Experience

A professional CRA is required to both develop and write trial protocols. The clinical trial protocol is important because it describes the purpose and methodology of the trial at hand. In order to correctly steer committees, the CRA must also be able to present trial protocols and design case report forms concerning the clinical trial.

Directing with Ethics Committees

It lies in the hands of the CRA to coordinate with the ethics committee. This is necessary to ensure the safety and wellbeing of the volunteers who are participating in the trial.

Managing Regulatory Authority Applications

The right CRA will be more than able to manage regulatory authority applications and approvals. According to Prospects, these documents are used to oversee the “research and marketing of new and existing drugs”.

Identifying and Assessing

There is a great deal of close assessment required in this line of work, including the identification of suitable trial sites, the selection of a responsible investigator and reviewing competitive landscapes.

Setting up Trial Sites

The process of setting up trial sites involves ensuring that the right trial equipment is available in each of the centres involved. The investigational medicinal product should also be available. In addition to this, each member of staff on site should be trained to meet the trial-specific standards in the industry.

Premarket Notification, otherwise known as a 510(k) is required when a person wishes to market a device intended for human or animal use. Submitting a 510(k) to the FDA is necessary in circumstances where a Premarket Approval is not required. Such devices that may require a 510(k) to market in the United States include Class I, Class II, and Class III devices. You may assume that submitting a 510(k) involved filling out stacks of official FDA forms of some sort. However, this is actually far from the case. Continue reading An Introduction to Premarket Notification 510(k) →