This module focuses on rigorous regulatory oversight of pharmaceutical products to ensure quality, safety, efficacy, and patient access. Companies must navigate a complex and evolving regulatory environment that varies by jurisdiction and is shaped by market access, pricing, reimbursement policies, and stakeholder expectations throughout the product lifecycle. It primarily addresses the EU regulatory framework for medicinal products and its influence on global markets. The Regulatory Affairs section covers requirements for product development, time-to-market, and lifecycle management through case-based learning, strengthening the ability to work with internal teams and regulators. The Pharmacovigilance section introduces EU requirements for building and managing systems that ensure patient safety, including organization, quality management, audits, inspections, and PV tools.
- Explain the fundamental principles and practical functions of Regulatory Affairs and Pharmacovigilance (PV) within the pharmaceutical industry
- Compare and contrast regulatory requirements for medicinal products across major markets (EU and US), including the influence of Health Technology Assessment (HTA)
- Describe and assess the key responsibilities, workflows, and organizational structure of Pharmacovigilance and Regulatory Affairs departments
- Evaluate the implications of Regulatory Affairs and PV activities on budgeting and resource allocation, considering both strategic and operational needs
- Assess the advantages and limitations of engaging with external strategic and operational partners in the context of Regulatory Affairs and PV
This course is part of the prestigious part-time Pharma MBA program, conducted in English on Fridays and Saturdays on Campus Westend. It offers a valuable opportunity to network and gain expertise without committing to a full degree program. Upon completion, participants receive a Certificate of Participation. As the number of seats is limited, we recommend to register early. If you're a GBS or Goethe University alum, explore our attractive alumni discount options.
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Dr. Jürgen Hönig
Dr. Jürgen Hönig works as a freelance consultant in Regulatory Affairs. Previously, he was Senior Director of Regulatory Business Intelligence with over 25 years of experience. He managed global submissions for clinical trials, new marketing approvals, and lifecycle activities. He also led process improvements and provided Regulatory Affairs benchmarking consultancy. From April 2020 to September 2024, he analyzed industry trends impacting Cencora PharmaLex's services. Jürgen studied Pharmacy at Heidelberg University, earned a PhD from Goethe University, and then worked in hospital pharmacy and academic research.
Reinhold Schilling M.D.R.A
Reinhold Schilling, M.D.R.A., is an experienced leader in Global Pharmacovigilance, currently serving as Head of Global Pharmacovigilance & EU QPPV at Wörwag Pharma and AAA-Pharma. With over seven years of leadership experience, he oversees risk management activities, patient safety compliance, and regulatory commitments. In his role, he fosters strong leadership within his team and mentors interns and graduates, offering technical and management skills. Previously, he worked in Pharmacovigilance and Regulatory Affairs, gaining expertise in case management, signal detection, and inspections.
Candidates with an undergraduate degree (i.e., bachelor or equivalent) of 180 credit points (CP) based on the European Credit Transfer System (ECTS) can apply for our Open Programs. The allocation of credit points for work experience will appear on the Academic Transcript of Records and be titled ‘Prior Learning Assessment’.
Open Program applicants must submit a recent proof of English language proficiency at the higher B2 level per the Common European Framework of Reference (CEFR). The GBS Office of Admissions will accept test results of the following tests, taken no longer than two years ago upon the date of submission:
- TOEFL iBT®
- TOEFL iBT® Home Edition
- IELTS
- Cambridge Certificate of Proficiency in English
- English Language Level Test (ELLT) - Oxford International Digital Institute
Applicants may request a waiver of proof of proficiency in English in case one of the following conditions applies. The applicant
- is a native speaker of English;
- has graduated from an international baccalaureate program
- has completed their undergraduate or master-level studies in a program taught entirely in English;
- has worked in an English-speaking country for at least one year.
If the applicant has not taken any of the above tests when submitting the application, the applicant can upload a confirmation of the test registration to the online admissions portal.
Applicants who submit a language certificate older than two years but without an expiry date will be invited for an additional interview with a native speaker of English.
Proof of relevant post-undergraduate work experience of at least one year is to be submitted, e.g., a performance review, reference letter, or written confirmation from your employer.