Pharmaceutical products are highly regulated in most countries in order to protect public health. These regulations are in place to ensure that the products meet appropriate quality, safety and efficacy standards.
In this module, special attention will be paid to medicinal products, with the other product groups, e.g., medical devices only being included in the considerations on a case-by-case basis. Although most healthcare industries are marketing their products regionally or globally, we will mainly focus on the EU legal framework, however, we will consider the impact of EU strategies for Clinical Development, Authorization Procedures and Lifecycle Management also for other markets.
The Regulatory Affairs section of this course will be dealing with certain aspects of the regulatory framework affecting the duration of development of a new product, the time to-be-market and the challenges of maintenance in the markets. This course will use interactive elements, e.g., learning with cases. This will help students to communicate with appropriate stakeholders involved at their organization, for example, Drug Development, Pharmacology, and Toxicology colleagues, as well as upper management and externally with Regulators within the Competent Authorities.
The Pharmacovigilance section of the course will build on this and introduce Pharmacovigilance in its broadest sense. The course is also an introduction to PV management in order to build up and manage an effective and compliant pharmacovigilance organization with budgeting, cost effective resource planning and smart PV tools and technologies.
This module will familiarize you with the basic concepts of operational RA and PV and the challenges various types of pharmaceutical companies may face, including pharmacovigilance audits and regulatory inspections.
Any questions?
This course is offered in the part-time Master of Pharma Business Administration MBA program and may be attended on a “no credit” basis by individuals not enrolled in the program. Course participants are visitors who are not responsible for assignments and do not take an exam or earn academic credits. As the number of seats in the course is limited, we recommend to register online early.
Upon completion of this course, you will be able to understand:
- The basics and practical insights of regulatory affairs and pharmacovigilance
- Key differences in drug regulation across major markets (EU and US)
- Challenges of designing efficient regulatory strategies
- Major PV tasks and organization of the Pharmacovigilance departments
- Budgeting and resource planning
- Pros and cons of working with strategic partners
The course will cover the following topics:
- Getting familiar with main EU regulatory agencies and their impact on daily business
- Meeting regulatory requirements and working with the regulatory authorities during drug development and clinical trial phase
- Basics of European pharmaceutical regulations on medicinal products – throughout product lifecycle
- Regulatory strategy considering also HTA and digital transformation
- Introduction to Pharmacovigilance (PV)
- Management and organization of the PV department including Resource planning and Budgeting
- Set-Up of a Pharmacovigilance System, Role of the Qualified Person responsible for Pharmacovigilance (QPPV), Key Pharmacovigilance Processes (i.e. Case Processing, Pharmacovigilance Agreements, Risk management and Crisis Management)
- Introduction to the Quality Management System for PV: Requirements for written procedures, PV Key Performance Indicators (KPIs), Communication lines, Audits and inspections, Training, Compliance and performance of the system
- Basic understanding of the safety database and relevant PV tool: Legal requirements, workflow, e-reporting, vendor selection process and migration of legacy cases
Course materials
Course materials will be provided in electronic form.
Language
English
Certificate of participation
A GBS certificate of participation is awarded upon completion of the course.
Course Fee
€ 1,900 (fee is exempt from VAT). The fee for GBS students or alumni amounts to € 800.
| Date | Session |
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| Dates coming soon |