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.
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 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).
Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Including an update on the new (Draft) ICH M4Q(R2) and the Draft of the Revision of the Classification Guideline. Take the chance to participate in our virtual seminar and get qualified.
To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.
