With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.
Combined offer of three compulsory seminars plus one elective module for (future) Heads of the Pharmacovigilance Department - learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.
Combination of three selected seminars - with this qualification course, you will first gain insight into the legal aspects and general responsibilities of the Qualified Person for Pharmacovigilance (QPPV). You will then deepen your professional and practical knowledge to perform your role more effectively.
LAST CALL! - REGISTRATION DEADLINE: 2.09.2025 - Four live webcasts à 2 hours every week: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs at your fingertips!
Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system in a profitable way. Reserve your seat now and be part of this insightful session!
CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).
Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Take the next step in your professional growth - enrol now!
Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!
This online conference covers EU regulatory developments, best practices for patient-centric labelling, digital transformation through ePI, and the latest innovations in labelling technology.
Get your know-how on creating and maintaining quality data for biotech products in our online training. Including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2).
