InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$490 USD / 27500 INR.
Buy NowBook Now
Loading
Loading
pharmacovigilance and drug safety training

Introduction

Eligibility

Certification

Features

Related Courses

About PV

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
  • Duration of the course: 1 Month
  • Nature of the course: Self Paced Learning. Online distance learning course. So, course can be accessed online across anywhere 24×7.

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.

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
Lecture 8Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 9Types and Timing of Non-clinical Studies 
Lecture 10USFDA expedited programs
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Handling of orange book
Lecture 14Purple Book: Significance | Searching | Assignments
Lecture 15Review on Drug Discovery and Development 
Section 2Clinical Program | Real World Evidences
Lecture 16Clinical Trials Terminologies 
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19Informed Consent | Practical Training in Preparing ICF | Templates
Lecture 20PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 21Bioequivalence Study | Study design | Different types of BE Studies
Lecture 22Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 23Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 24Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 25RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 26RWD and RWE in Product Lifecycle Management
Lecture 27RWD and RWE - Fit to use | Assessment
Lecture 28RWD data sources | Different types | Detailed understanding of each class 
Lecture 29RWD Study Design
Lecture 30Consensus Narrative Review 
Lecture 31Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics
Section 3Pharmacovigilance and Drug Safety Management
Lecture 32Introduction to Pharmacovigilance |Definition| Importance |Focus Area | Regulatory compliance | PV activities 
Lecture 33Introduction to ADR | Definition | Importance of ADR management | Classification | Prevention of ADR
Lecture 34Terminologies related to ADR 
Lecture 35ADR Reporting System | ADR information loop | ADR reporting system in various countries
Lecture 36DoTS
Lecture 374 Elements of AEs
Lecture 38ADR Seriousness Determination 
Lecture 39ADR Reporting Limitations
Lecture 40ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 41PSURs
Lecture 42Pharmacovigilance Application Path
Lecture 43Pharmacovigilance Risk Management 
Lecture 44REMS Strategic Planning 
Lecture 45Coding and ADR | MedDRA Principle of ADR Coding | Level of terms | Case Study
Lecture 46MedDRA Coding | Level of terms | Multi Axial Terminology | Practical Example Case Discussion 
Lecture 47The International Conference on Harmonization (ICH) - Role in Pharmacovigilance Management
Lecture 48Active surveillance schemes
Lecture 49Pharmacovigilance Databases : VigiBase | FDA Adverse Event Reporting System (FAERS) | EudraVigilance | MedWatch  | Canadian Vigilance Program| UK Yellow Card Scheme | Chinese Adverse Drug Reaction Monitoring System (CAMS) 
Lecture 50The Summary of Product Characteristics (SmPC, SPC)
Lecture 51Signal Detection | Process | Different Types of Signal Detection Methods 
Lecture 52Signal Detection in post-marketing surveillance
Section 4Pharmacovigilance Framework
Lecture 53Pharmacovigilance Framework
Lecture 54Corporate Pharmacovigilance Program 
Lecture 55National Pharmacovigilance Program 
Section 5Pharmacovigilance Software
Lecture 56Pharmacovigilance Software
Lecture 57ICSR in E2B Format | E2B(R3)