Good Pharmacovigilance

Practice Training

Good Pharmacovigilance

Practice Training

Pharmacovigilance is a completely developed area of pharmaceuticals. Generally

shortened to PV; pharmacovigilance is that area of life sciences which deals with all

aspects of the adverse side effects of medicines and biologics. PV works mainly with

clinical studies. In this process, it gathers, invigilates, and researches and assesses from all the parties involved in the medical and biological arenas, such as patients,

healthcare providers, pharmaceutical organizations and many others.

Ever since the safety aspects of medicines have taken center stage; PV has gained

currency as a specialized area. It is usually used in the stage prior to human testing,

or what is called Phase I of clinical studies. This is natural, because a drug that is

administered without being subject to PV is likely to cause damage to humans. If the

drug escapes PV and enters the market; it is likely to cause problems across large

sections of the society. It could lead to other issues such as loss of name for the manufacturer.

Helps build steps for drug

development

A sound pharmacovigilance system helps in the continuous development of a drug. This is a means of insulating the clinical trial and subsequently, the drug from all the negative fallouts associated with not complying with guidelines on pharmacovigilance.

It is clear from these points that pharmacovigilance is an area of utmost importance to pharmaceuticals. In addition, it is also understood and accepted to be complex, because

there exist not only innumerable laws on PV; they need the help of professionals to unravel and understand.

Professional trainings in

pharmacovigilance from NetZealous LLC

NetZealous LLC, a highly reputable provider of professional trainings in the

areas of regulatory compliance, human resources, healthcare and IT, is at the

forefront of providing professional trainings to help clinical professionals and

those in pharmaceuticals get the nuances of pharmacovigilance. Its experts

are senior professionals from the industry and bring in collective experience that stretches to several decades. Their experience and wisdom has helped

thousands of professionals comply with regulatory guidelines for their

industry.

How do NetZealous LLC’s professional trainings benefit

clinical professionals? The benefit that professionals in the field of clinical trials get from trainings from

NetZealous LLC is that they understand the dynamics of not just the textual

aspects of the laws on pharmacovigilance as they apply in different markets

around the globe, but also the way in which they need to be practically

administered. This helps them to stay clear of the problems associated with noncompliance, which attracts heavy penalties and punishments from regulatory

bodies.

For instance, there are huge differences in the ways pharmacovigilance laws

apply to the US and the EU. While the major commonality of the US’ regulatory body, the FDA and the European one, the European Medicines Agency, or the

EMA, is the objective of ensuring the safety of the product that requires reports

about the adverse events; there are differences in their approaches. NetZealous

LLC’s professional trainings help clinical professionals understand the differences that exist between the two.

Understanding the

differences

The US FDA focuses on the complete stages of the product, right from

the discovery of the new molecule to its conversion to medicine to its

marketing and consumption. The FDA, unlike the EMA, does not

require a risk management plan to be in place when the drug is being

marketed. It has a sound plan that emits signals whenever there is an

adverse effect from a clinical trial.

The EMA’s strong requirements

The EMA has been ushering in major changes from July 2012 onwards, when it

enacted strong and new legislation relating to post-marketing. As a result, there have

been major changes in its pharmacovigilance requirements. Now, on account of these

changes, the EMA requires the following:

• Pharmaceutical companies that carry out clinical trials have to name a qualified

person who will be assigned oversight for ensuring pharmacovigilance with the

EMA;

• This person will be required to set up a pharmacovigilance system master file

(PSMF). All details relating to all aspects of the company’s pharmacovigilance, as

well as what steps the pharma company has taken for ensuring that robust signal detection for pharmacovigilance and management, need to be described here.

• The PSMF should also contain details relating to aspects such as screening of

literature elements and requirements relating to risk management, most of which

are different from and more stringent than those set out by the FDA, because an

adverse effect has to be reported within a fortnight of the event, and a non-serious

event, within 90 days.

It is perception of matters like these that trainings from NetZealous LLC impart.

This is why pharmacovigilance trainings from NetZealous LLC are a dire need

for clinical professionals. These trainings help them understand the elements of

these regulatory requirements, which is absolutely essential for ensuring that the

clinical trial meets pharmacovigilance requirements.

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