FORUM Institut für Management GmbH: 17 Produkte
Clinical Trial Project Management - Skills, Tools, and Methods for Successful Clinical Drug Trials
Die Themen - Project management - tools, plans & documentation - Managing the "people-business" - skills and methods - Setting up a project…
Pharmaceutical Marketing Authorisation and Market Access in the Middle East: GCC and National Markets - Connect with regional experts from …
Die Themen - Pharmaceutical marketing authorisation and market access in the GCC and key national markets - Intellectual property: Patents,…
Variations in Europe - Practical Guidance on Classification, Submission and Current Regulatory Updates
Die Themen - Variation Regulation (inlcuding new features since 01.01.25) - Classification and submission (including new features since 15.…
CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe
Die Themen - Regulatory requirements in the EU and the ICH region - Update on the new (Draft) ICH M4Q(R2) - Essential quality data for mark…
Pharmacovigilance Auditing - Planning and conducting GVP Audits
Die Themen - Qualifications and responsibilities according to GVP Module IV - Conducting effective interviews - Auditing of PV documents, c…
All about ATMP - Development - Quality - CMC - Authorisation - Market Access
Die Themen - From blood, tissues & cells to ATMP - GMP and Module 3 requirements for ATMPs - Requirements for clinical and non-clinical dev…
Global Regulatory Affairs Essentials - Key Strategic and Operational Aspects
Die Themen - Strategic Planning - Global Regulatory Collaboration - Health Technology Assessment (HTA) Integration - Global Regulatory Doss…
Marketing Authorisation in Latin America - Focused insights on regulatory strategies in Brazil, Mexico, Argentina, Colombia, Chile and Peru
Die Themen - LATAM pharmaceutical landscape: market potential, harmonisation trends and regional dossier formats - National procedures and …
An Introduction for Pharmacovigilance Managers - Start your career in Drug Safety
Die Themen - Regulatory framework and EMA GVP modules - Management of side effects and signals - Benefit-risk assessment and risk managemen…
Regulatory Affairs and GMP compliance in Eastern Europe - Considerations for the EAEU and Non-EAEU markets
Die Themen - Regulatory Framework and Requirements - Approval Processes and Documentation - Product Management and Maintenance - Quality Ma…
Pharmacometrics modeling in Monolix - Various (guided) hands-on units included
Die Themen - Concepts of modeling, PK modeling and model diagnostics - Statistical model building and covariate selection - PKPD modeling a…
Munich Licensing Summer Course - 2 day comprehensive course covering all aspects
Die Themen - Pre-licensing considerations - Anatomy of a license agreement - Typical clauses - Commercial use of IP rights: 25 % rule and m…
GenAI Patent Munich Spring Camp
Die Themen - Generative AI for patent search, drafting, prosecution, litigation and analysis - Legal requirements and technical realities -…
The EU Qualified Person for Pharmacovigilance (EU QPPV) - The intensive beginner's course on legal foundations and practical application
Die Themen - Legal framework, liability, and legal protection - Regulatory requirements for day-to-day practice - Maintaining oversight of …
Toxicology and beyond: Safety assessment in drug development - Know-how for employees in R&D, Medical affairs, Regulatory affairs & Pharmac…
Die Themen - Pharmacokinetics and toxicokinetics - Safety pharmacology and photosafety evaluation - Genotoxicity, carcinogenicity, reproduc…
