Introduction to Pharmacovigilance for non-Pharmacovigilance Personnel

Pharmaceutical companies are required, by law, to provide adequate training to their employees so that they are able to identify and report adverse events.

While many companies will have a programme in place to facilitate this training, it may not always be possible to make this immediately available to every new starter. Equally, the existing programme may be labour intensive to maintain or deliver.

PIPA has therefore developed a cost-effective generic online training course that provides the legally required level of training for all employees working for a Pharmaceutical Company so that they are able to recognise and report adverse events. It has been developed by senior Pharmacovigilance experts working within the Pharmaceutical Industry so you can be confident of the quality and relevance of the training. It is up-to-date with current regulations and, once you have passed the test at the end of the training course, a formal certificate is provided to confirm course completion and understanding.

 Target audience: Any employees working for a Pharmaceutical Company – this course provides the legally required level of training on identifying and recording AEs

 Time: 1 -2 hours

Level of difficulty: Basic / introductory

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

How to facilitate a successful product launch

Aimed primarily at Medical Information personnel, this course looks at the role of the Medical Information team in ensuring a successful product launch.

Divided into 5 sections, the course covers:

  • Early inclusion in the product launch team
  • Medical Information department requirements
  • Marketing and sales force support
  • External communications and notifications
  • Timelines.

Using practical advice, and helpful checklists, this course is a useful tool for Medical Information teams supporting new product launches.

 Target audience: Medical Information professionals preparing for a product launch

Time: 1 -2 hours

 Level of difficulty: Introductory / intermediate

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

 

GVP Module XV – Safety Communication

If you are looking to get to grips with the regulations and guidelines for communicating and coordinating safety information in the EU (to include patients and healthcare professionals), this course will provide you with a good introduction and equip you with the fundamental principles.

The course is written by Pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module XV (Safety Communication) of the Guideline on Good Pharmacovigilance Practices released by the European Medicines Agency in January 2013.

This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with Drug Safety e.g. all Medical Information professionals. It is also an ideal course for those providing medical review and for PV professionals with a number of years of experience, but who would like a refresher and/or require evidence of their training on, and understanding of, the GVP Modules.

Accessing this course will enable delegates to:

  • Understand the objectives and principles of Safety Communication
  • Learn who your target audiences are
  • Understand the content and means of safety communication
  • Review key elements of safety communication operation within the EU regulatory network

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience:

New PV professionals

Individuals in departments that work closely with PV

Those providing medical review

PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module XV

 Time: 1 -2 hour

 Level of difficulty: Introductory / intermediate

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

 

GVP Module VI: Management and Reporting of Adverse Reactions to Medicinal Products

If you’re looking to get to grips with the regulations and guidelines for the collection and reporting of adverse events, this course will provide you with a good introduction and equip you with the fundamental principles of Pharmacovigilance.

The course is written by Pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module VI (Management and reporting of adverse reactions to medicinal products) of the Guideline on Good Pharmacovigilance Practices released by the European Medicines Agency in June 2012.

This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with drug safety e.g. all Medical Information professionals. It is also an ideal course for those providing medical review and for  PV professionals with a number of years of experience, but who would like a refresher and/or require evidence  of their training on, and understanding of, the GVP Modules.

Accessing this course will enable delegates to:

  • Learn the key definitions and industry terms
  • Find out more about the European regulations and guidelines
  • Understand what adverse events are and how they are collected
  • Learn how to identify an adverse event
  • Know what information to collect for an adverse event report
  • Learn the reporting timeframes

Links are provided to other important sources of information.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience:

New PV professionals.

Individuals in departments that work closely with PV

Those providing medical review

PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module VI

 Time: 1 -2 hours

 Level of difficulty:Introductory / intermediate

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

GVP Module IX: Signal Management

 

 

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

GVP Module V: Risk Management Systems

If you’re looking to get to grips with the regulations and guidelines for risk management systems, this course will provide you with a good introduction and equip you with the fundamental principles

The course is written by Pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module V (Risk Management Systems) of the Guideline on Good Pharmacovigilance Practices released by the European Medicines Agency in June 2012.

This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with Drug Safety e.g. Medical Information professionals. It is also an ideal course for those providing medical review and for PV professionals with a number of years of experience, but who would like a refresher and/or require evidence of their training on, and understanding of, the GVP Modules.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience: New PV professionals; Individuals in departments that work closely with PV; Those providing medical review; PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module IV

 Time: 1 -2 hours

Level of difficulty: Introductory / intermediate

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

GVP Module IV: Pharmacovigilance Audits

If you’re looking to get to grips with the regulations and guidelines for pharmacovigilance audits, this course will provide you with a good introduction and equip you with the fundamental principles.

The course is written by Pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module IV (Pharmacovigilance Audits) of the Guideline on Good Pharmacovigilance Practices produced by the European Medicines Agency.

This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with Drug Safety e.g. all Medical Information professionals. It is also an ideal course for those providing medical review and for PV professionals with a number of years of experience, but who would like a refresher and/or require evidence of their training on, and understanding of, the GVP Modules.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience: New PV professionals ; Individuals in departments that work closely with PV; Those providing medical review; PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module IV

 Time: 1 -2 hours

 Level of difficulty: Introductory / intermediate

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

GVP Module III: Pharmacovigilance Inspections

If you’re looking to get to grips with the regulations and guidelines for pharmacovigilance inspections, this course will provide you with a good introduction and equip you with the fundamental principles.

The course is written by Pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module III (Pharmacovigilance Inspections) of the Guideline on Good Pharmacovigilance Practices produced by the European Medicines Agency.

This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with Drug Safety e.g. all Medical Information professionals. It is also an ideal course for those providing medical review and for PV professionals with a number of years of experience, but who would like a refresher and/or require evidence of their training on, and understanding of, the GVP Modules.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience:  New PV professionals; Individuals in departments that work closely with PV; Those providing medical review; PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module IV

 Time: 1 -2 hours

 Level of difficulty: Introductory / intermediate

Booking and payment

 

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

GVP Module I: Pharmacovigilance Systems and their Quality Systems

If you’re looking to get to grips with the regulations and guidelines for pharmacovigilance systems and their quality systems, this course will provide you with a good introduction and equip you with the fundamental principles of Pharmacovigilance.

The course is written by pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module I (Pharmacovigilance Systems and their Quality Systems) of the Guideline on Good Pharmacovigilance Practices released by the European Medicines Agency in June 2012.

This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with drug safety e.g. all Medical Information professionals. It is also an ideal course for those providing medical review and for PV professionals with a number of years of experience, but who would like a refresher and/or require evidence  of their training on, and understanding of, the GVP Modules.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience:  New PV professionals. Individuals in departments that work closely with PV.  Those providing medical review
PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module VI

 Level of difficulty: Introductory / intermediate

 Time: 1 -2 hours

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.

Data Protection

PIPA is delighted to be able to offer a specialist online training course on data protection specifically for the pharmaceutical industry.

The course has been written by Amanda Kearsley, a data protection solicitor and director of law:matix.

law:matix is a specialist law firm that focuses solely on privacy, data and technology law. Further information about Amanda and law:matix can be found via www.lawmatix.com

 Target audience:  All professionals working within the pharmaceutical industry who require training on data protection

 Time: 1 -2 hours

 Level of difficulty: Introductory / intermediate

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.