This document outlines guidelines for virtuous pharmacovigilance practices as presented by Dr. Nancy Agnes of Pepgra Group. It discusses the need to protect patients and public health through pharmacovigilance. The introduction describes pharmacovigilance systems and their responsibility for drug safety authorization. Key principles for guidelines include meeting patient and public needs, providing Good Pharmacovigilance Practice guidelines, and continuous quality improvement. Responsibilities of pharmacovigilance organizations include ensuring qualified staff, adequate resources, and a systematic approach to quality.

1. GUIDELINES ON VIRTUOUS
PHARMACOVIGILANCE
PRACTICES
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pepgra
Group: www.pepgra.com
Email: pepgrahealthcare@gmail.com

2. Today's Discussion
In-Brief
Introduction
Quality Cycle
Quality Objectives of Pharmacovigilance(GVP)
Principles of Pharmacovigilance Guidelines
Responsibilities for the Quality System of a Pharmacovigilance Organization
Conclusion
OUTLINE

3. In Brief
Does the need for protection of patients and public health increasing?
Unquestionably yes. The science of regulating and understanding this process
is known as pharmacovigilance for all clinical research organization. Medical-
related problems for the Clinical trial Monitoring Services have a considerable
impact on the pharmacovigilance process as it detects, monitors and analyze
the medical activities says the world health organization(WHO). Pepgra
explains the general guidelines that apply to the EU legislation to promote the
regulations in health care sectors.

4. Introduction
Pharmacovigilance system is an organization that fulfils
all the legal process and regulations that are related to
medicinal products and detecting its adverse effects.
This system is responsible for the safety authorization
for all medical products.
For every specific process pharmacovigilance, there
are several guidelines and safety measures and a
committed module.
Pepgra lists the basic ad general guidelines for these
practices included in GVP with the help of Clinical
Biostatistics services.

5. Quality Cycle
The quality system must be having the following
activities a pharmaceutical regulatory consulting
services should look after,
Planning of quality- creating new structures
and integral planning for consistent processes
Adherence of quality- Perform the tasks and
duties according to the available quality
requirements for the processes.
Contd..

6. Quality assurance and control- investigating and evaluating the structure of the
processes should be practical and useful in medical care sectors.
Improvements in quality- improving and correcting the procedure wherever it is
necessary for healthcare data analytics services.

7. Quality
Objectives of
Pharmacovigilance
(GVP)
Documenting the legal requirements that are
required to perform pharmacovigilance tasks
and duties.
Protecting humans from the adverse effects
causing from authorized medical products
inside or outside the marketing exposure.
Building safe and practical applications of medical
products to the patients and the public using
pharmacovigilance literature search services.
Contd..

9. Principles of
Pharmacovigilance
Guidelines
The principles listed are a few basic principles that
should be processed during the design of structures
while conducting all tasks in pharmacovigilance
processes.
To meet the needs of patients, medical
professionals and the common public to
analyze the safety regulations of medicines in
the clinical study design process
Provide guidelines for GVP ( Good
Pharmacovigilance Practices)
Contd..

10. The hierarchies should give leadership for implanting quality system and motivate
all the employers to the quality objectives for pharmacovigilance processes
All persons in the organization must be involved in and encourage the
pharmacovigilance processes based on task ownership and responsibility in a degree
to their tasks and assigned duties accordingly.
All staff members involved with the entire company should apply in continuous quality
improvement according to their quality system cycle
Contd..

11. Resources and tasks must be organized as a structure and proceed in a manner that
supports the risk-proportionate, proactive, continuous and integrated process of the
pharmacovigilance Literature review search.
The available evidence for the risk-benefit balance of medical products must be
sought and relates to the aspects, that could impact on the risk-benefit ratio, and
product users must be considered for any decision-making processes.
A good organization must be foster to all the healthcare professionals, marketing
authorization holders, public health organizations, patients, competent authorities,
learned societies and other relevant bodies following the applicable legal provisions.

12. Responsibilities
for the Quality
System of a
Pharmacovigilance
Organization
An adequate number of well-qualified professionals
should be available for performing the
pharmacovigilance tasks.
They must possess certain qualities and fulfil specific
duties for a systematic approach in the qualitative
medical practices accordingly to quality cycle. They are
To ensure that the documents providing quality
check are relevant to the papers controls the
approval and implementation of subjects.
To check that sufficient resources are available for
training is provided.
Contd..

13. To ensure that the premises, facilities and equipment are readily available for the
processes.
To verify that the given compliance management is sufficient.
To provide adequate management of records.
To review the pharmacovigilance is verifying the risk and adverse effects of the
medicinal products and increasing quality system.
To introduce the control measures wherever necessary.
Contd..

14. To guarantee that the given mechanisms and clinical study protocol exist timely.
To escalate the safety concerns of the healthcare products.
To identify the medical errors and non-adherence documents of the quality systems
To investigate the requirements and action plan regularly
To check the audits are cleared
Motivating and creating interests to all the staff members based on shared values
Contd..

15. To appoint a good leader
To provide freedom and right to speak to all the staff members
To fulfil the staff's requirements by investigating their contributions to the organization
assign roles accordingly
To check their potential abilities and give promotions for the development of the
organization
To check the functioning of the quality system and to make sure that the organization
implements quality in the pharmacovigilance practices with a systematic approach

16. Conclusion
These are a few essential guidelines essential for
in therapeutics clinical research acceptable
pharmacovigilance practices.
Patient's health and safety is the most critical and
challenging task for all the medical sectors.
These can be achieved with the systematic approach
of the pharmacovigilance services with the help of this
Pepgra blog.

17. UNITED KINGDOM
+44- 7424810299
INDIA
+91-9884350006
EMAIL
pepgrahealthcare@gmail.com
Contact Us