Training & Webinars
⟶ Equip your pro’s with expert skills
Our ambition is to equip your team with world class abilities in their areas of expertise. We offer practical and interactive training on various regulatory topcis in the pharmaceutical, food supplement and medical device industry.
Many of our courses were designed to be done in-house but can – depending on your individual needs – also be held as webinars..
Available courses
Pharma Management
A 3-day practical & interactive training on management matters in life sciences.
Reach your full potential through managers and employees who can handle the challenges that confront every business.
- Strategy and strategic thinking
- Controlling and managing complex commercial relationships
- Business, commercial and financial skills
- Competitive marketing
- Leading and managing strategic change
Combination Products
A 2-day practical & interactive training on how to register combination products.
It will give attendees a complete practical understanding of the regulatory framework of combination products in the EU and US.
- Variations, pharmacovigilance/vigilance, packaging and labelling requirements, format and content of the CTD/STED
- The complex regulatory environment involving combination products
- Suitable for pharmaceutical/biotech and medical device manufacture
Labelling & packaging
A complete technical understanding of the regulatory framework of labelling in the EU.
Delegates will gain a complete insight into important guidelines, legislation, the summary of product characteristics, the patient information leaflet and variations submissions.
- Important guidelines and legislation
- Product characteristics (SmPC)
- Patient information leaflet (PIL) and labels
- Readability guidelines
- Variations submissions / deficiency letters
China Regulatory Affairs
A series of 4 webinars. Duration: 60min. Price: € 150.
- State Administration for Market Regulation (SAMR), National Medical Products Administration (NMPA), Center of Drug Evaluation (CDE), National Institution of Food and Drug Control (NIFDC), etc.
- Change history, roles and main responsibilities
- Important regulation/policy reform highlights
- CTA process in China, including the start-up procedures: Ethical Committee (EC) application, human subject samples importation application
- CTA dossier preparation highlights
- CMC requirements
- Change management during CTA
- Foreign clinical trial data acceptability
- CTA ‘Silent approval’ database
- Clinical trial registry
- MAA pathways overview, including the fast MAA approval
- MAA dossier preparation highlights, CMC requirements
- Master file bundling review: Requirements for the Application Data of API, excipients and packaging materials
Marketing authorization holder system, overseas inspection overview
- CMC requirements important highlights during IND and MAA stage
- Testing strategies during IND and MAA for chemical and biological products
- Testing procedures and requirements
Documents, material preparation, interaction with testing agency, such as National Institution of Food and Drug Control (NIFDC)
Regulatory Affairs Strategies
Practical information on effective drug registration processes.
Best practices for integrating regulatory requirements from early stages of development and advice on how to develop RA project teams and strategies that work for both you and the regulators.
- Drug Discovery
- Clinical Phases
- Approval of Marketing Authorization Applications (MAA)
- Regulatory Affairs beyond the MAA
SOPs
Ensure compliance with written Standard Operating Procedures (SOP), especially in GMP (Good Manufacturing Practice) environments.
- Pharmacovigilance
- Regulatory procedures
- Change control
- Artwork and labelling processes
- Pharmacovigilance
- IT and software related matters
Pharmacovigilance
How to establish an appropriate system of pharmacovigilance in the European Economic Area (EEA).
- Pharmacovigilance systems
- Risk management systems
- Vigilance reporting
- Post Market Surveillance (PMS)
- Standard operating procedures (SOP)
Quality management
- Principles of quality management
- Requirements clarification
- Role of quality management
- Post market / production surveys
- IT and software related matters
Risk management
- Principles of risk management
- Requirements clarification
- Possible hazard analysis and control methods
- Find the best suitable approach for your company and products
Biocompatibility Testing
- Principles of biocompatibility testing
- Requirements clarification
- Appropriate test(s) for your product
- Choose between testing and/or bibliographical reviews
Contact us
Contact us for more information, to book a training or to talk about your individual training plan.