Pharmacovigilance

Pharmacovigilance

Pharmacovigilance (PV) is the science and set of activities aimed at detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems throughout a medicine's life cycle. It is crucial for monitoring the benefit-risk balance of medicines to ensure patient safety, covering everything from pre-approval clinical trials to post-marketing surveillance. Effective PV allows regulatory authorities to take action to improve the safe use of medicines. 


Key aspects of pharmacovigilance include:

  • Safety Monitoring: Identifying previously unrecognized adverse effects or changes in patterns of known side effects.
  • Signal Detection: Analyzing individual case safety reports to identify potential new risks
  • Risk Management: Implementing measures to minimize risks, such as updating product information (Summary of Product Characteristics) or using tools like the "Black Triangle" scheme for closely monitored, new medicines.
  • Reporting Requirements: Collecting data from various sources (clinicians, patients, literature) and reporting to regulatory authorities like the MHRA (via the Yellow Card scheme) or EMA.

Scope: Beyond adverse drug reactions (ADRs), modern PV covers lack of efficacy, medication errors, misuse, abuse, and pregnancy exposure. 

Safety oversight and the ability to interact professionally in a complex world, is what our three levels of online PV training support.

1)      All must know how to identify and report an ADR.
2)      Those in PV or interacting with PV benefit from a broad understanding of PV obligations and tasks.
3)      Those handling PV on a national scale needs additional support to fulfil their role.

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Fantastic rates available for groups of 5 or more participants - contact us for details

Our ‘on demand’ training is supported by certificates and can be downloaded conveniently on any smart device/phone.


Our online brochure can be found at https://brookwood-global.com/Books/Online-Training-Brochure/

 


Are you ready for ... a PV inspection?

Are you ready for ... a PV inspection?

 Are you ready for … a PV inspection?               &nb..

£100.00

PV for ALL

PV for ALL

This 15 min* ‘Step 1’ online pharmacovigilance (PV) training is for an entire organization’s staff. ..

£50.00

Essential PV - Know PV

Essential PV - Know PV

Essential pharmacovigilance training for those who need greater detail.       ..

£100.00

PV for the Local Safety Contact and L-QPPV Online Training

PV for the Local Safety Contact and L-QPPV Online Training

Responsibilities of the company’s Local Safety Contact and the additional obligations of a L-QPPV. ..

£100.00

PV Refresher

PV Refresher

An interactive Q&A to update and refresh PV knowledge.            ..

£100.00

Essential Safety Reporting for the Investigator Site

Essential Safety Reporting for the Investigator Site

This course is essential for all investigators needing to have awareness of their safety reporting o..

£50.00

e-book PV for All

e-book PV for All

A desk-side reference to dealing with product safety issues, for all!        ..

£3.00

e-book Essential Pharmacovigilance

e-book Essential Pharmacovigilance

An overview of a marketing authorization holders PV responsibilities.        ..

£15.00

PV for All Book

PV for All Book

This short easy-to-read booklet is for all staff in an organization who might encounter a product sa..

£5.95

Essential Pharmacovigilance Book

Essential Pharmacovigilance Book

This book is relevant to everyone involved in pharmacovigilance, both directly and indirectly throug..

£8.95

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