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Virtual Classroom: Essentials of Pharmacovigilance

Basel,

June 10 @ 10:00 am - July 1 @ 12:00 pm CEST

 

NEW: Live virtual Instructor-led Training Course
This training workshop will take place in a virtual format via a digital platform. Bite-sized training sessions of 2 hours spread across 1-2 weeks; start date is 10th June 2020. Delivered at set times with live trainer interaction enable you to ask questions and discuss theory to ensure a comprehensive understanding. More details to follow…

 

The purpose of this virtual workshop is to create an understanding of the key aspects of Pharmacovigilance (PV). It will provide an overview and introduction to the definitions such as sources of cases, MedDRA (Medical Dictionary for Regulatory Activities) coding, case processing, and a first glance at a PV database. It is designed for anyone who wishes to achieve an understanding of the essentials of pharmacovigilance.

Course Objectives

  • Get a grasp on essential definitions of PV
  • Learn a good approach to MedDRA coding
  • Understand the origin of cases and how to determine their validity
  • Learn to distinguish between solicited and unsolicited cases
  • Develop case assessment and processing skills
  • Gain a first impression of a PV database

Course Modules

Module 1: 10th June – 10:00-12:15 am (2.15hrs)           

  • Introduction of participants and trainers             
  • Overview of agenda
  • Legal Basis
  • Definitions
    • Adverse Events
    • Adverse Reactions
    • Event vs. Case
    • Seriousness
    • Valid and non-valid cases
    • Hands-on exercise: Valid or not?

Module 2: 22nd June – 10:00-12:00 am (2hrs)

  • Expectedness
  • Causality
  • Unblinding
  • Sources of cases
    • Spontaneous („unsolicited“) reports
    • Regulatory Authorities / EudraVigilance
    • Literature and Internet
    • Non-interventional Studies („solicited“)
    • Clinical Trials (“solicited”)
  • Hands-on exercise: Classification of solicited and unsolicited cases

Module 3: 23rd June – 10:00-12:00 am (2hrs)             

  • Do you speak MedDRA?
    • Definition and Development of MedDRA
    • Scope/ Purpose of MedDRA
    • Structure of classification and clarification of MedDRA terms (SOC, PT, LLT, etc.)
    • Update and Support
  • Browsing advices
  • Hands-on exercise: MedDRA coding examples

Module 4: 1st July – 10:00-12:15 am (2.15hrs)

  • Case processing
    • Receipt and confirmation
    • Duplicate Check, MedDRA Coding
    • Triage
    • Data Entry, Narrative Writing
    • Medical Assessment
    • QC
    • Submission
    • EudraVigilance
  • Demonstration of an E2b compliant database

Interactive activities are core part of each module to help you test and confirm you have met the learning objectives.

Who should attend?

This workshop has been designed for anyone who wishes to achieve an understanding of the essentials of pharmacovigilance. Especially for newcomers in pharmacovigilance and/or those working in associated areas such as Clinical Operations, Medical Information, Regulatory, Affairs etc.

Course Leaders

Dr. med. Susanne Kienzle-Horn, Senior Consultant, SCRATCH Pharmacovigilance GmbH, Germany
studied medicine and informatics and started working in the pharmaceutical industry in 1990. In addition to her more than 25 years of PV experience resulting from practical work in this area, she has wide-ranging soft skills in areas like leadership, training and coaching. She is the founder of SCRATCH Pharmacovigilance GmbH, a service provider who supports, advises and trains pharmaceutical entities in Europe in all areas of pharmacovigilance.

Magnus Lühring, PV Training Specialist, SCRATCH Pharmacovigilance GmbH, Germany
started to work for SCRATCH Pharmacovigilance in 2005, directly after having completed his professional education as ‘Medizinischer Dokumentar’ (medical documentalist). His focus lies on ICSR processing in several PV databases, ICSR submissions to regulatory authorities, XEVMPD product maintenance, as well as lecturing and co-lecturing of PV seminars and MedDRA workshops. Since 2009, he is a “Certified MedDRA Coder” and, since 2014, he bears the title of “TÜV Certified PV Manager”.

Continuing Education

This course is accredited by the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM).

Fee:

Registration Fee: CHF 790.00 + 7.7% VAT
15 % reduction for SwAPP and SBA members
Special fees for CTC employees
Special rates available for PhD Students
Please contact training@ctcresourcing.com

The fee includes course documentation. Upon completion of the online survey participants will be able to get their certificate of attendance.
Payment: After registration, you will receive confirmation and an invoice with instructions on how to complete the bank transfer. Full prepayment is needed prior to the course start date.

Cancellation Policy:

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund
In case of no show, no refund will be made.

Document:

Essentials of PV pgm-flyer.pdf

Virtual Classroom: Online Registration Form

Details

Start:
June 10 @ 10:00 am
End:
July 1 @ 12:00 pm

Venue

Virtual Classroom
remotely via digital platform Switzerland
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