Variations in Europe
Seminar
Online
Beschreibung
-
Kursart
Seminar
-
Methodik
Online
Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room!
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Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Management
Inhalte
Detailed programme
Day1: 09:00 - 17:00 seminar
Day 2: 09:00-17:00 seminar
09:00
Lidia Cánovas
Basics, fundamentals & classification
- Variation Regulation, Classification guideline
- Changes according to the Variation Regulation vs purely national changes
- PACMP
10:00
Lidia Cánovas
Type IA-Notification
- Type IA-changes according to the classification guideline
- Annual report
- Immediate notification (Type IAIN)
10:30 Coffee break
10:45
Kora Doorduyn-van der Stoep
Type IB-Variations
- Type IB-changes according to the classification guideline
- Timelines and processing
- Type IB by default
11:15
Lidia Cánovas
Type II-Variations
- Processing of type II variations
- Timelines, submission and validation
12:00 Lunch
13:00
Kora Doorduyn-van der Stoep
Grouping and Worksharing
- Grouping of type IA notifications
- Grouping of extensions and other variations
- Grouping of different types of variations
- Practical examples
- Efficient variation management
14:00
Lidia Cánovas
Variation submission
- E-only, consequences for MA dossier
- Variation (e)-Application Form
- CESP submission
- Technical requirements
15:15 Coffee break
15:30
Lidia Cánovas
Special notification of change
- Safety related changes and urgent safety restrictions
- Line Extensions; "Unforeseen" Variations
16:00
André Mota
Variation Management
- Strategic planning and deadlines
17:00 Day 1 ends
09:00
André Mota
Changes in the production process
- Notification or variation
- Batch size change
- Change in the manufacturing flow
- Tech transfer/site transfer?
10:30 Coffee break
10:45
Dr Regina Heckenberger
Changes in the formulation
- API and excipient new suppliers
- How to assess a change and build a submission plan
- Challenges
12:15 Lunch
13:15
Dr Veronika Alt
Changes in the analytics - changes of:
- Contract laboratories
- Analytical methods
- Acceptance criteria/Specifications
- Regulatory change control management
14:30 Coffee break
14:45
Dr Regina Heckenberger
Package and production changes
- Primary/secondary packaging (specification, testing)
- Change of packaging sites
- Labelling impact
16:00
All speakers
Practical examples and case studies
16:00
All speakers
...Variations in Europe