InstructorRoyed Training
TypeOnline Course
Price$490 USD / 24500 INR.
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Pharmacovigilance and drug safety


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About Pharmacovigilance

pharmacovigilance and drug safety

This online self paced training course provides advanced training of pharmacovigilance and drug safety management.

This course is to create pharmacovigilance manager for Pharmaceutical, Biopharmaceutical Industry. This pharmacovigilance training course gives practical knowledge and real life job simulation. Course focus on how pharmacovigilance professionals work in company and understanding of key responsibilities and job functions.

In this online self-paced modules, participant will develop competency on the pharmacovigilance management process in detail. Course covers fundamental to advanced learning on drug safety management. Participant will learn about Adverse events, ADR case processing, Pharmacovigilance Reporting Database, Signal Detection, Managements And Risk Assessments and Evaluation. Above all, course will focus on how to handle pharmacovigilance software.

Course Title: Advanced Certification in Pharmacovigilance and Drug Safety
Course Code: RYD-048

Who should attend this course? 

  • Those who are in pharmacovigilance department working in pharmaceutical companies or drug regulatory agency.
  • Professionals from IT industry, who are working in pharmacovigilance software and wants first hand information on pharmacovigilance and drug safety.
  • Anyone requiring an overview of pharmacovigilance.
  • Fresher or beginners, Those who want to make a career in pharmacovigilance.

Online distance learning course. So, course can be accessed online across anywhere 24×7.

1 Year

Any body who wants to acquire pharmacovigilance and drug safety competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

  • Course provides in-depth understanding on pharmacovigilance process. Hence, it provides orientation to job related practical aspects of pharmacovigilance.
  • Simulation to real life working in pharmacovigilance department. Therefore, it help to enhance the pharmacovigilance strategic decision making.
  • Moreover, course provides advanced training on ADR Reporting and Signal Detection Systems, Pharmacoepidemiology, Causality Assessment of Suspected Adverse Drugs Reactions.
  • Pharmacovigilance program also provide in depth understanding how to set up a Pharmacovigilance Center in Industry.
  • In conclusion, this online training course provides 360 degree learning for effective Management of Pharmacovigilance Data and Risk Management.

What is pharmacovigilance?

“Pharmacovigilance ” (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. Hence,  Its aims are to enhance patient care and patient safety and to support public health programmes by providing reliable, balanced information for the effective assessment of the benefit-risk profile of medicines and vaccines.

Is pharmacovigilance and drug safety is same?

In reality Pharmacovigilance is same as drug safety. In addition Drug Safety is a broad term that describes the collection, analysis, monitoring and prevention of adverse effects in drugs and therapies. However, Drug Safety Management is a completely scientific and process-driven within pharmaceutical and biopharmaceutical industry.

What is an adverse event?

The definition of an adverse event is any reaction within a patient’s body caused by a drug or development molecule – a side effect.  A serious adverse event is a life-threatening side effect that causes hospitalization, incapacity, permanent damage or, in extreme cases, the death of a patient. Adverse event reporting is must for all clinical research investigators, even if the side effects are only suspected.

The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy. In other words, analyzing which side effects are worth the risk to patients compared with how effective they are at treating a disease. For instance, chemotherapy may cause some serious side effects but when faced with life-threatening cancer, these side effects are considered acceptable given the potential to cure a patient. However, if a drug used to cure a headache caused similar side effects, the risk to the patient would be considered too great and the benefit not substantial enough to justify the potential damage.

What is the difference between pharmacovigilance and regulatory affairs working? >> Click here to learn

Section 1Drug Discovery and Development
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Section 2Clinical Research
Lecture 8Clinical Trials Terminologies 
Lecture 9Clinical Trial Protocol Writing
Lecture 10Ethics in Clinical Research
Lecture 11Informed Consent | Practical Training in Preparing ICF | Templates
Section 3Pharmacovigilance and Drug Safety Management
Lecture 12Introduction to Adverse Drug Reactions
Lecture 13ADR: Pharmacology
Lecture 14ADR Controversies
Lecture 15ADR: Classification
Lecture 16PV and ADR Monitoring
Lecture 17ADR and Related Terminologies
Lecture 18ADR Reporting System 
Lecture 19DoTS
Lecture 204 Elements of AEs
Lecture 21ADR Reporting Limitations
Lecture 22ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 23Introduction: Pharmacovigilance Process
Lecture 24PSURs
Lecture 25Risk Management
Lecture 26Pharmacovigilance regulatory authorities : USFDA
Lecture 27MedDRA
Lecture 28Pharmacovigilance Regulation in Emerging economies, including Latin America
Lecture 29European Union - Pharmacovigilance Process
Lecture 30World Health Organization (WHO) - Role in PV Management | WHOART | CIOMS
Lecture 31The International Conference on Harmonization (ICH) - Role in Pharmacovigilance Management
Lecture 32The International Society of Pharmacovigilance (ISoP)
Lecture 33Active surveillance schemes
Lecture 34EudraLex
Lecture 35Pharmacovigilance Framework
Lecture 36The Summary of Product Characteristics (SmPC, SPC)
Lecture 37Pharmacovigilance Software - Practical understanding 
Lecture 38Effectiveness of Pharmacovigilance Software
Lecture 39National Pharmacovigilance System
Lecture 40Good PharmacovVigilance Process (GPVP) Framework