Drug Safety and Pharmacovigilance Training in Reston, VA

• Identifying the adverse effects of pharmaceutical drugs
• Monitoring the effects of any changes made on pharmaceuticals
• Understanding the audits/inspections methodology
• Handling the audits/inspections and responses to requests
• Legal and contractual basis of audits/inspections
• Appreciation of regional differences
• Preparing responses to audit/inspection findings, including responses and corrective/preventive action (CAPA) plans
• Preparing their function for an audit/inspection such as roadmap, teams, tasks and documents
• Drug Safety Database

Drug Safety or Pharmacovigilance refers to activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It ensures the best out­come of treatment with medicines. Any good pharmacovigilance will identify the risks after the medicine has been marketed and will help to establish and identify risk factors.

Class 1.1:

• What is Pharmacovigilance?
• Benefits of PV
• Uses of PV

This chapter teaches you about the relation between epidemiology and evidence-based medicine. Epidemiology defines that branch of medicine which is related to incidence, distribution, control of diseases and all other factors relating to health. Evidence refers to the collection, definition, and findings from scientific research. Evidence plays a significant role in public health decision and policies.

Class 2.1:

• About Epidemiology
• About Evidence Based Medicine (EBM)
• Relationship between epidemiology and evidence-based medicine

The quality of healthcare can be increased based on the training and knowledge provided to clinicians about the principles of pharmacovigilance. You can enhance patient care by practicing the principles and by getting educated about the drug safety, health policy, and clinical experiences.

Class 3.1:

Importance of Pharmacovigilance
Impact on patient welfare and public health
Labeling and risk management

This chapter teaches about the System Organ Classes which indicates the disorders of a body system or disorders in a group of organs which together perform a particular function.

Class 4.1:

• Pharmacovigilance and System organ classes
• ADRs in various fields
• Drug safety and ADRs

Pharmacovigilance systems provide improved access to Pharmaceuticals and Services. A pharmacovigilance system is unique by its structures, processes, and outcomes. The systems ensure the availability of quality pharmaceutical products and efficient pharmaceutical services to achieve desired health outcomes.

Class 5.1:

• About Pharmacovigilance systems
• Quality Products
• Challenges for Pharmacovigilance systems

This chapter introduces you to the pharmacovigilance that is used by organizations to complete their legal tasks and responsibilities with regards to pharmacovigilance and primarily designed to monitor the safety of authorized medical products and detect any change to their risk-benefit balance.

Class 6.1:

• Conditional regulations
• Professional Standard regulations

Class 7.1:

• Concepts and principles in epidemiology
• Epidemiological tools  
• Advantages of epidemiological tools  

This chapter allows you to learn and understand the local and worldwide regulations and guidelines on Pharmacovigilance.

Class 8.1:

Concept of Pharmacovigilance regulations
Working Pharmacovigilance regulations
Other related Pharmacovigilance regulations and guidelines

A Drug safety specialist or a Pharmacovigilance Specialist receives and reports adverse events reported by investigators. The important duty of a drug specialist is to prepare safety report and submit it to the regulatory authorities, perform research and provide medical and scientific information to the health care professionals within the company. Pharmacovigilance Specialist is responsible for the efficient development of the safety management plan and maintaining the safety database.