Qualification course: CMC-Specialist in Regulatory Affairs
One basic module, 3 advanced seminar modules - you determine the focus and the time frame
- You get the basis in CMC management
- You choose individually 3 advanced training modules
- You save up to 30% compared to the regular seminar booking
Modulare Weiterbildung
Ab
4.500,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 4.500,-€ zzgl. MwSt.
payable up to 21 days after receipt of the total invoice or in partial invoices for each training date. The fee includes course documentation for download and a certificate.
Period:
A few weeks to a maximum of 18 months, depending on the module booked.
Buchungsdetails
Modulare Weiterbildung
Ab
4.500,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 4.500,-€ zzgl. MwSt.
payable up to 21 days after receipt of the total invoice or in partial invoices for each training date. The fee includes course documentation for download and a certificate.
Period:
A few weeks to a maximum of 18 months, depending on the module booked.
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.
Your speakers
Dr. Margit Schnee
CSL Vifor, SWITZERLAND
Senior Regulatory Affairs Manager CMC
Dr Schnee worked for several years at CureVac N.V. in non-clinical research on mRNA-based vaccines. Still at CureVac, she later switched to…
Your speaker
Dr. Margit Schnee
CSL Vifor, SWITZERLAND
Senior Regulatory Affairs Manager CMC
Dr Schnee worked for several years at CureVac N.V. in non-clinical research on mRNA-based vaccines. Still at CureVac, she later switched to Regulatory Affairs CMC.
With her experience she moved to CSL Vifor in 2020 and has since been responsible for Regulatory Affairs CMC for already approved products, combined with further new approvals worldwide.
Dr. Helmut Vigenschow
ViPharmaService,
Burgrieden
Independent Consultant
Dr Vigenschow worked for Merckle/ratiopharm for 30 years in leading positions, including in the areas of project management, regulatory affairs,…
Your speaker
Dr. Helmut Vigenschow
ViPharmaService,
Burgrieden
Independent Consultant
Dr Vigenschow worked for Merckle/ratiopharm for 30 years in leading positions, including in the areas of project management, regulatory affairs, pharmaceutical development, quality assurance and quality control.
Dr Vigenschow has been working as an independent consultant for several years now.
Dr. Martina Dressler
Teva GmbH,
Ulm, GERMANY
Change Control Manager
Dr Martina Dressler earned her doctorate in materials research (small molecules).
She is a pharmacist with many years of experience in the pharmaceutical…
Your speaker
Dr. Martina Dressler
Teva GmbH,
Ulm, GERMANY
Change Control Manager
Dr Martina Dressler earned her doctorate in materials research (small molecules).
She is a pharmacist with many years of experience in the pharmaceutical industry at Teva ratiopharm, initially in RA Generic Maintenance and for more than 10 years in the GMP-regulated environment in the area of Quality Assurance (Change Control Management).
She currently focuses on the lifecycle management of generics and biogenerics as well as the project management of change control applications.
For several years, she has been a member of core teams at the site, coordinating the interfaces (QA-CMC-RA).
Dr. Andrea Förster
pharmaand GmbH
Vienna, AUSTRIA
Head of CMC
Dr Andrea Förster has over a decade of experience in the pharmaceutical and chemical industry, with a strong focus on CMC, quality, and manufacturing. Her…
Your speaker
Dr. Andrea Förster
pharmaand GmbH
Vienna, AUSTRIA
Head of CMC
Dr Andrea Förster has over a decade of experience in the pharmaceutical and chemical industry, with a strong focus on CMC, quality, and manufacturing. Her professional path includes roles in development and production, including CMC analytics, supporting EU, U.S., and global markets. In 2024, she joined pharma& as Head of CMC, where she is responsible for the strategic direction and coordination of CMC activities across the product portfolio.
What to Expect
- You determine the main topics of the training course yourself. ### Possible areas of focus are:
- Development methods
- Manufacturing processes
- CMC documents
- Change management
- Analytics
- Specifics for biologics
- Requirements in different countries/regions
- and more
Who Should Attend
This qualification course is aimed at employees of the pharmaceutical industry and their service providers who require in-depth know-how in CMC topics.
Objective of the Event
Would you like to have profound know-how in CMC topics, remain flexible in terms of time and set your own content priorities? Then this is right for you.
The concept: You start with a two-day basic seminar "CMC Management in Regulatory Affairs" (talking about the english course) and then select three further seminar modules (= 3 seminar days) that support your professional development.
You will qualify as a CMC-Specialist in a maximum of 18 months (or in just a few weeks) and receive certification from the FORUM Institute.
In this way, you can achieve your training goal efficiently and precisely.
Your Benefit
- You receive a comprehensive basis in CMC management.
- You can individually select the advanced training modules according to your professional orientation.
- You have up to 18 months to complete your individual training and you can even adapt the training schedule during the course.
- You save up to 30% compared to regular bookings.
- You receive a FORUM certificate on successful completion of the qualification.
Programme
09:00 - 17:00
- Regulatory Framework and Requirements - Approval Processes and Documentation - Product Management and Maintenance - Quality Management and GMP Audits - International Markets and Opportunities
09:00 - 17:00
- Concept:Four weekly live webcasts à 2 hours with longtime experienced speakers - Regions covered:China India Japan/South Korea Russia/EAEU - Your benefits:Possibility to directly interact with the speaker;You will receive a certificate after each session;You are unable to attend one of the sessions? Profit from the recording of each webcast!
09:00 - 17:00
- Regulatory expectations and CMC requirements (as currently in place to ICH Q3E) - Industry strategies for current global E&L requirements - ICH Q3E under development: Scope and key principles from an authority perspective - From draft to operations: How industry can prepare for ICH Q3E
09:00 - 17:00
- Structure and presentation of Module 3 and Module 2 - CTD sections in detail: S-Part, P-Part, specific sections - Country specific requirements, e.g. China, Japan, Brazil, etc. - Considerations for NCEs and generics - Case studies and exercises
09:00 - 17:00
- Overview and scope of ICH guidelines - Manufacturing processes, impurities, specifications and stability - Structure of CTD module 3.2.S, changes according to ICH M4Q(R2) - ASMF and CEP procedures - e-submission requirements to active ingredients - Global approval relevant API changes: Challenges & opportunities
09:00 - 17:00
- Regulatory landscape in the US - Scientific advice - The IND and BLA procedure - Post-approval/maintenance: Procedures and documentation - Requirements for the handling of quality data - Hot topics and current challenges
09:00 - 17:00
- Regulatory requirements in the EU and the ICH region - Update on the new (Draft) ICH M4Q(R2) - Essential quality data for marketing authorisation - CMC documentation:Module 3, ASMF, CEP and Quality Overall Summary - Management of post-approval changes - Classification of quality related variations
09:00 - 17:00
- The new EMA quality guideline: Structure and core requirements- CDMO (Contract Development and Manufacturing Organisation) contribution to CMC strategy and regulatory dossier integration - The sponsors perspective: Owning CMC strategy across the lifecycle
09:00 - 17:00
- From QbD (ICH Q8) to designed lifecycle management (ICH Q12): How to make the most of ICH Q12 opportunities - Special considerations and challenges for biologics - ICH Q8 and ICH Q11: Mastering QbD concepts - ICH Q9 and Q10: "Tools" to implement QbD - ICH Q12: Interpretation and implementation
09:00 - 17:00
- Regulatory landscape and testing requirements - Bracketing & matrixing, storage conditions and shelf-life - Dossier structure and post-approval changes - Challenges for biologicals products - Global stability program
09:00 - 17:00
- Adaptation from EU and differences within Latam (Latin America) - CMC requirements in Brazil, Mexico, Colombia, Argentina,Chile, Peru: Documentation, country specific requirements, post-approval activities, future trends in the regions
09:00 - 17:00
- CMC writing conventions - Pharmaceutical development - Description of the manufacturing process and of analytical procedures - GMP aspects and CMC content - The quality part of the IND/IMPD along pre-/clinical development - Working with service providers and compilation of the CTD
09:00 - 17:00
Regulatory Affairs and GMP compliance in Eastern Europe
Regulatory Affairs and GMP compliance in Eastern Europe
- Regulatory Framework and Requirements - Approval Processes and Documentation - Product Management and Maintenance - Quality Management and GMP Audits - International Markets and Opportunities
09:00 - 17:00
Global CMC requirements: focus on Asia, Japan, and Eastern Europe
Global CMC requirements: focus on Asia, Japan, and Eastern Europe
- Concept:Four weekly live webcasts à 2 hours with longtime experienced speakers - Regions covered:China India Japan/South Korea Russia/EAEU - Your benefits:Possibility to directly interact with the speaker;You will receive a certificate after each session;You are unable to attend one of the sessions? Profit from the recording of each webcast!
09:00 - 17:00
Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E
Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E
- Regulatory expectations and CMC requirements (as currently in place to ICH Q3E) - Industry strategies for current global E&L requirements - ICH Q3E under development: Scope and key principles from an authority perspective - From draft to operations: How industry can prepare for ICH Q3E
09:00 - 17:00
CMC Writing
CMC Writing
- Structure and presentation of Module 3 and Module 2 - CTD sections in detail: S-Part, P-Part, specific sections - Country specific requirements, e.g. China, Japan, Brazil, etc. - Considerations for NCEs and generics - Case studies and exercises
09:00 - 17:00
APIs in the dossier: Quality data, e-submission, global regulatory strategy
APIs in the dossier: Quality data, e-submission, global regulatory strategy
- Overview and scope of ICH guidelines - Manufacturing processes, impurities, specifications and stability - Structure of CTD module 3.2.S, changes according to ICH M4Q(R2) - ASMF and CEP procedures - e-submission requirements to active ingredients - Global approval relevant API changes: Challenges & opportunities
09:00 - 17:00
CMC dossier requirements: FDA vs EU
CMC dossier requirements: FDA vs EU
- Regulatory landscape in the US - Scientific advice - The IND and BLA procedure - Post-approval/maintenance: Procedures and documentation - Requirements for the handling of quality data - Hot topics and current challenges
09:00 - 17:00
CMC Management in Regulatory Affairs
CMC Management in Regulatory Affairs
- Regulatory requirements in the EU and the ICH region - Update on the new (Draft) ICH M4Q(R2) - Essential quality data for marketing authorisation - CMC documentation:Module 3, ASMF, CEP and Quality Overall Summary - Management of post-approval changes - Classification of quality related variations
09:00 - 17:00
Radiopharmaceuticals: A practical CMC and quality perspective
Radiopharmaceuticals: A practical CMC and quality perspective
- The new EMA quality guideline: Structure and core requirements- CDMO (Contract Development and Manufacturing Organisation) contribution to CMC strategy and regulatory dossier integration - The sponsors perspective: Owning CMC strategy across the lifecycle
09:00 - 17:00
Mastering ICH Quality Guidelines: From Development to Lifecycle Management
Mastering ICH Quality Guidelines: From Development to Lifecycle Management
- From QbD (ICH Q8) to designed lifecycle management (ICH Q12): How to make the most of ICH Q12 opportunities - Special considerations and challenges for biologics - ICH Q8 and ICH Q11: Mastering QbD concepts - ICH Q9 and Q10: "Tools" to implement QbD - ICH Q12: Interpretation and implementation
09:00 - 17:00
Global stability: From regulatory framework to practical application
Global stability: From regulatory framework to practical application
- Regulatory landscape and testing requirements - Bracketing & matrixing, storage conditions and shelf-life - Dossier structure and post-approval changes - Challenges for biologicals products - Global stability program
09:00 - 17:00
Global CMC requirements: focus on Latin America/Latam countries
Global CMC requirements: focus on Latin America/Latam countries
- Adaptation from EU and differences within Latam (Latin America) - CMC requirements in Brazil, Mexico, Colombia, Argentina,Chile, Peru: Documentation, country specific requirements, post-approval activities, future trends in the regions
09:00 - 17:00
CMC writing excellence: From development data to CTD content
CMC writing excellence: From development data to CTD content
- CMC writing conventions - Pharmaceutical development - Description of the manufacturing process and of analytical procedures - GMP aspects and CMC content - The quality part of the IND/IMPD along pre-/clinical development - Working with service providers and compilation of the CTD
Downloads
Request the documents using our form.
Brochure
Weitere Informationen
This is how you create your individual training schedule
You attend the two-day basic course "CMC Management in Regulatory Affairs".
Afterwards you participate in 3 further modules (= seminar days).
How to book
This course is so individual that I will be happy to advise you personally. Please contact me directly at b.wessels@forum-institut.de or Tel. 06221 500 652. I will be happy to help you with the module selection and will be happy to assist you with financing questions too.
You start with this module
Informationsbeauftragte - Fokus Packmittel
Seminar für Informationsbeauftragte: Rechtliche Grundlagen der Arzneimittelkennzeichnung, Verantwortungsabgrenzung, SOPs und praktische Fehlerquellen-Prävention.Sprache: Deutsch
Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E
E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation…Sprache: Englisch
Outsourcing & Vendor Oversight in Regulatory Affairs
Overview of RA outsourcing & vendor oversight: risk-based vendor selection, governance and compliance controls. Practical and compact in just half a daySprache: Englisch
Market Access of Biosimilars in Europe
Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market accessSprache: Englisch
Update eCTD 4.0
Get up to speed on eCTD 4.0: EU timelines, technical changes, transition requirements and pilot learnings - all in one focused half-day session including a live demo.Sprache: Englisch
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de