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Post Graduate Award in Pharmacovigilance
- Flexible study concept with self-study and live webinars
- Certificate with exam and 10 ECTS
Pharmacovigilance covers the safety and risk issues one must address to ensure patients receive safe drugs. This course will give students a working knowledge of all aspects of drug safety monitoring and risk management, enable them to predict and analyse drug interactions and recognise the implications for prescribing and product license. The student will also be familiar with pharmacovigilance best practice, including monitoring strategies and action plans, and will be fully cognizant of regulatory reporting requirements.
After successfully completing this course, students will be able to:
Understand and critically appraise the principles of pharmacovigilance and landmark cases effecting change to recent drug safety issueExplain key operational drug safety definitionsDemonstrate good pharmacovigilance practice and locate key sources of information and documentationComprehend and discuss global pharmacovigilance Understand drug development and discuss the risks and safety assessment Critically explain the strengths and weakness of pharmacovigilance reporting systemsfuture challenges in drug safety and pharmacovigilance
More information
Topics covered in the course:
• Historical aspects and evolution of drug safety
• Safety of Drugs
• Risk assessment and risk management
• Absorption, distribution, metabolism and excretion (ADME)
• Device safety
• Collecting and reporting drug safety information
• Audit and inspection
• Pharmacovigilance planning
• Regulatory requirements and legislations in the EU and MENSA
• Future challenges in drug safety and pharmacovigilance
All live webinars will be recorded and can be viewed again at any time and as often as you like. So if you have missed one of the webinars it is no problem. If you have any questions you can contact the speaker or simply ask your questions in the next live webinar.
Your benefits of the live webinars
✔ Flexible
✔ Location independent
✔ Participate live or watch the webinar later at your own leisure
✔ Ask your questions directly to the speaker
✔ Discussion with other participants
| Week | Theme | Title | Duration (hours) | Date | Time (German time) |
1 | Introduction of Pharmacovigilance | Overview of Pharmacovigilance | 1 | 02. Feb 21 | 17.30 |
1 | Introduction of Pharmacovigilance | Standard Terms And Terminology | 1 | 03. Feb 21 | 17.30 |
1 | Introduction of Pharmacovigilance | Regulatory Guideline & Laws | 1 | 04. Feb 21 | 17.30 |
2 | Drug Development Process | Preclinical Phases | 1 | 10. Feb 21 | 17.30 |
2 | Drug Development Process | Clinical Trial Phases | 1 | 11. Feb 21 | 17.30 |
3 | The Principles of Pharmacovigilance | Premarketing Pharmacovigilance | 1 | 17. Feb 21 | 17.30 |
3 | The Principles of Pharmacovigilance | Postmarketing Pharmacovigilance | 1 | 18. Feb 21 | 17.30 |
4 | Case Processing | Single Case Processing | 1 | 23. Feb 21 | 17.30 |
4 | Case Processing | MedDRA Dictionary and Coding of | 1 | 24. Feb 21 | 17.30 |
4 | Case Processing | Single Case and Group Narrative | 1 | 25. Feb 21 | 17.30 |
5 | Reference Safety Information (RSI) | Investigator Brochure (IB) | 1.5 | 03. Mrz 21 | 17.30 |
5 | Reference Safety Information (RSI) | Core Data Sheet (CDS/local labels) | 1.5 | 04. Mrz 21 | 17.30 |
6 | Adverse Drug Reactions | Individual Case Safety Report (ICSR) | 1 | 09. Mrz 21 | 17.30 |
6 | Adverse Drug Reactions | Case Assessment‐Medical review of | 1 | 10. Mrz 21 | 17.30 |
6 | Adverse Drug Reactions | Case Assessment‐ Practical | 1 | 11. Mrz 21 | 17.30 |
7 | Aggregated Safety Reports | DSUR - General Introduction | 1 | 17. Mrz 21 | 17.30 |
7 | Aggregated Safety Reports | DSUR- Template Report and their Completion | 1 | 18. Mrz 21 | 17.30 |
8 | Aggregated Safety Reports | PSUR/PBRER - General Introduction | 1 | 24. Mrz 21 | 17.30 |
8 | Aggregated Safety Reports | PSUR/PBRER - Template Report and their Completion | 1 | 25. Mrz 21 | 17.30 |
9 | Signal Management Process | Concept, Input, Periodicity and Materials | 1 | 30. Mrz 21 | 17.30 |
9 | Signal Management Process | Signal Validation and Prioritisation | 1 | 31. Mrz 21 | 17.30 |
9 | Signal Management Process | Signal Evaluation, Evaluation of Risk and Recommendations | 1.5 | 01. Apr 21 | 17.30 |
10 | Signal Management Process | Practical Examples | 1 | 07. Apr 21 | 17.30 |
10 | Signal Management Process | Drug Safety Report | 1 | 08. Apr 21 | 17.30 |
11 | Risk Management Plan (RMPs) | General Introduction | 1 | 14. Apr 21 | 17.30 |
11 | Risk Management Plan (RMPs) | Template Report and Their Completion | 1 | 15. Apr 21 | 17.30 |
12 | The Big Picture | How It All Fits Together | 1.5 | 21. Apr 21 | 17.30 |
12 | The Big Picture | Take Home Points and Quiz | 1 | 22. Apr 21 | 17.30 |
As of January 2021, subject to change.
Yolanda Narain
Highly motivated and experienced project manager, with a PhD in Biological Sciences, Prince 2 Project Management certification, Team Facilitator and more than 15 years of experience in pharmacovigilance, compliance and project management. Skilled in leading and managing a wide range of national/international cross-functional projects and teams, ensuring compliance, and an appropriate stakeholder management.
Established in 2018, we are one of the few private education providers offering a wide range of training programmes for the dental team and all healthcare professionals. Working across a blended learning concept, we aim to reach out to all aspiring individuals to improve their knowledge and skills. Our collaboration with Ulster University enables us to offer a wide range of career progression opportunities.
Contact | Information material
For further information about course content, company terms or our in-house seminars please get in touch with us via email or phone. We look forward to hearing from you.
Elina Deutrich
Springer Campus Marketing
Tel.: +49 (0) 6221 487 8428
E-mail: elina.deutrich@springernature.com
Registration | Further information about the course
Course:
Online (live webinars) and self-directed learning
Co-operation partner:
College of Medicine and Dentistry, Birmingham (UK)
Duration| Workload:
12 weeks
300 hours: 30 contact hours (live webinars) and 270 of directed self-learning.
Level:
Level 6 degree in Pharma, Biomed, Medicine or equivalent
English test: The College of Medicine and Dentistry will do an English test (free of charge) internally to the students. The English test will be one hour maximum and will assess the applicant competencies in Speaking, Reading, Writing and Listening. The test will be focused on pharma issues. This will tick the English Language requirements for the course.
Certificate:
Certificate of the College of Medicine and Dentistry (Birmingham) with 10 ECTS
Price:
€ 2.200,- (VAT-free)
Start:
Start: 02. February 2021 (Registration deadline: 26 January 2021) | 14th May 2021
Booking:
For Companies:
Companies can book this course for their employees at Springer Campus:
For private persons:
This course can also be booked directly by private persons:
Customer recruits customer
You have been or are currently a participant in a Springer Campus Certificate course and know someone in your circle of friends or colleagues who might also be interested in a course? Then you are welcome to recommend us to others! For every successful placement of a participant, you will receive a customer-recruits-customer bonus of EUR 50,-.