CTD: requirements for non-clinical/clinical modules and eCTD-readiness
Focus on small molecules and biologics
- Tipps for study Reports + clinical expert report
- Bibliographic CTD: specifics
- Tools for practical implementation
- Case studies + workshop
- Officially certified according to ISO 9001 + 21001
Online-Seminar
From
1.690,00 €
plus VAT
Services & Process
Veranstaltung - 1.690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day I: 9:00 am - 5:00 pm CET
Day II: 9:00 am - 2:00 pm CET
You may dial in 30 minutes before the lecture starts
Booking details
Online-Seminar
From
1.690,00 €
plus VAT
Services & Process
Veranstaltung - 1.690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Day I: 9:00 am - 5:00 pm CET
Day II: 9:00 am - 2:00 pm CET
You may dial in 30 minutes before the lecture starts
Non-clinical/clinical content in the dossier: Are you a beginner in the field and would like to feel confident working competently on modules 2, 4 and 5 in the future? Are you already an experienced specialist and would like to refresh, professionalise or "structure" your knowledge? Then you've come to the right place!
Your speakers
Dr. Alexandra Günzl
Karyon Biopharma Consulting e.U., Vienna, AUSTRIA
Non-Clinical Consultant and Founder
In early 2023 Alexandra Günzl founded Karyon Biopharma Consulting e.U. and supports clients as a non-clinical…
Your speaker
Dr. Alexandra Günzl
Karyon Biopharma Consulting e.U., Vienna, AUSTRIA
Non-Clinical Consultant and Founder
In early 2023 Alexandra Günzl founded Karyon Biopharma Consulting e.U. and supports clients as a non-clinical consultant in a wide range of issues related to non-clinical drug development. In her former position as Non-Clinical Consultant at MC Toxicology Consulting GmbH where she worked for more than 10 years, she contributed to the successful development of numerous drug candidates with a focus on biologics and ATMPs. She studied biotechnology with a focus on biomedicine and was trained in experimental cancer research during her PhD. Alexandra Günzl deepened her regulatory expertise through postgraduate training on "Regulatory Affairs of Biopharmaceuticals including ATMPs" (EUCRAF).
Nina Kappler
Kappler Pharma Consult GmbH, Leipheim, GERMANY
Pharmacist, MBA
, Managing Director
Team Leader Pharmakovigilanz & Team Leader Innovations
After studying pharmacy, she worked as a regulatory affairs…
Your speaker
Nina Kappler
Kappler Pharma Consult GmbH, Leipheim, GERMANY
Pharmacist, MBA
, Managing Director
Team Leader Pharmakovigilanz & Team Leader Innovations
After studying pharmacy, she worked as a regulatory affairs manager and took over the family business in 2019. She has more than 8 years experience in (WEU) submissions and regulatory strategy.
Dr. Sabrina Stöhr
Merck Healthcare KGaA, Darmstadt, GERMANY
Associate Director Medical Writing
After her studies in human and molecular biology and research in cell biology, Sabrina Stöhr focussed on clinical research.…
Your speaker
Dr. Sabrina Stöhr
Merck Healthcare KGaA, Darmstadt, GERMANY
Associate Director Medical Writing
After her studies in human and molecular biology and research in cell biology, Sabrina Stöhr focussed on clinical research. For more than 10 years, she has been working as a medical writer on the preparation of clinical authorisation documents in various therapeutic areas. She deepened her expertise with a Master's degree in Drug Regulatory Affairs (DGRA).
Dr. Hans Rensland
RACON Regulatory Affairs Consulting GmbH, Berlin
Independent Consultant
Dr Hans Rensland has 30 years of experience in clinical research and regulatory affairs. With his many years of professional…
Your speaker
Dr. Hans Rensland
RACON Regulatory Affairs Consulting GmbH, Berlin
Independent Consultant
Dr Hans Rensland has 30 years of experience in clinical research and regulatory affairs. With his many years of professional experience in the pharmaceutical industry, he founded his own consulting company in 2012.
What to Expect
- Non-clinical modules in the CTD: Challenges with modules 2.4, 2.6 and 4
- Clinical modules in the CTD: Challenges with modules 2.5, 2.7 and 5
- Workshop/working on realistic example scenarios
- Specific requirements for a bibliographic application
- eCTD-readiness
Who Should Attend
This online seminar is aimed at employees in pharmaceutical drug development who create, process or integrate/write non-clinical/clinical data into the marketing authorisation application dossier or people who will take on these tasks in the future.
In particular, employees in the drug authorisation, clinical research, R&D and medical science departments will benefit from the seminar.
Specialists from the phytopharmaceutical industry are also very welcome however, in general the focus will be on small molecules and biologics.
Objective of the Event
This online seminar will provide you with an overview of the relevant non-clinical and clinical data for preparing the authorisation application dossier.
You will discuss these questions with the experts, among others:
- Which data, graphs and tables must find their way into the CTD dossier?
- What are the requirements for the study reports?
- What are the regulatory requirements for the Clinical Expert Report?
- Dealing with literature data/"well-established use applications"
After attending the seminar, you will be able to work competently on modules 2, 4 and 5.
Your Benefit
Thanks to the numerous topic-specific and practical tips from our speakers and the application of what you have learnt during the workshop
- you will strengthen your competence in dossier compilation, dossier evaluation and dossier updates;
- you will improve your writing skills;
- you will be able to deal confidently with bibliographic data and
- you will be up to date on the topic of eCTD-readiness.
Programme
Day I: 9:00 am - 5:00 pm
Day II: 9:00 am - 2:00 pm
You may dial in 30 min before the training
Day 1
Dr Alexandra Günzl
- What is the CTD?
- Structure of the CTD
- Regulatory framework, relevant guidelines/Q&As
- Overview of the application procedure in the EU: basis for the dossier requirements (full vs. abbreviated dossiers)
- General requirements?
Dr Alexandra Günzl
- Module 2.4 and 2.6 What data must be included in the CTD? Where does the information come from? Where does which information go?
- Definitions of the different sections
- Specifications regarding the order of the studies (by animal species, type of application)
- What to pay particular attention to?
- Module 4
- Structure and requirements for the study reports
Short breaks of 5-10 minutes each, totalling 15-20 minutes, are included in the morning.
Dr Sabrina Stöhr
- Module 2.5 and 2.7
- What data must be included in the CTD?
- Where does the information come from?
- Where does which information go?
- Definitions of the different sections
- Specifications regarding the order of the studies
- What to pay particular attention to?
- Module 5
- Structure and requirements for the study reports
A short break of 5-10 minutes is included during this lecture.
Nina Kappler
- What is a bibliographic application?
- What are the specific requirements?
- What are the hurdles (including practical examples)?
- Outlook on legal framework
Welcome, introduction, expectations
Introduction to the topic
Introduction to the topic
Dr Alexandra Günzl
- What is the CTD?
- Structure of the CTD
- Regulatory framework, relevant guidelines/Q&As
- Overview of the application procedure in the EU: basis for the dossier requirements (full vs. abbreviated dossiers)
- General requirements?
Non-clinical modules in the CTD
Non-clinical modules in the CTD
Dr Alexandra Günzl
- Module 2.4 and 2.6 What data must be included in the CTD? Where does the information come from? Where does which information go?
- Definitions of the different sections
- Specifications regarding the order of the studies (by animal species, type of application)
- What to pay particular attention to?
- Module 4
- Structure and requirements for the study reports
Short breaks of 5-10 minutes each, totalling 15-20 minutes, are included in the morning.
Lunch break
Clinical modules in the CTD
Clinical modules in the CTD
Dr Sabrina Stöhr
- Module 2.5 and 2.7
- What data must be included in the CTD?
- Where does the information come from?
- Where does which information go?
- Definitions of the different sections
- Specifications regarding the order of the studies
- What to pay particular attention to?
- Module 5
- Structure and requirements for the study reports
A short break of 5-10 minutes is included during this lecture.
Bibliographic CTD
Bibliographic CTD
Nina Kappler
- What is a bibliographic application?
- What are the specific requirements?
- What are the hurdles (including practical examples)?
- Outlook on legal framework
Recap and outstanding questions
End of seminar day I
Day 2
Dr. Hans Rensland
- eCTD current and future basics
- eCTD as master and regional dossier(s)
- eCTD lifecycle management
- eCTD practical approach, experiences
Dr Alexandra Günzl and Dr Sabrina Stöhr
After you have had the opportunity to work individually on the different example scenarios (approx. 30 minutes), you will discuss the tasks in the respective small group (approx. 30 minutes).
The speakers are available the whole time for questions, discussions and tips, so that an exchange and thus a "learning effect" is also possible during the workshop. At the end, the results are discussed in the plenum.
Short breaks of 5-10 minutes each, totalling 15-20 minutes, are included in the morning.
eCTD-readiness
eCTD-readiness
Dr. Hans Rensland
- eCTD current and future basics
- eCTD as master and regional dossier(s)
- eCTD lifecycle management
- eCTD practical approach, experiences
Workshop
Workshop
Dr Alexandra Günzl and Dr Sabrina Stöhr
After you have had the opportunity to work individually on the different example scenarios (approx. 30 minutes), you will discuss the tasks in the respective small group (approx. 30 minutes).
The speakers are available the whole time for questions, discussions and tips, so that an exchange and thus a "learning effect" is also possible during the workshop. At the end, the results are discussed in the plenum.
Short breaks of 5-10 minutes each, totalling 15-20 minutes, are included in the morning.
End of the seminar
Downloads
Request the documents using our form.
Brochure
Whitepaper_Stability-Testing-of-Drug-Products
Weitere Informationen
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- Free technical pre-meeting to start off your training on the right foot
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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Further Information
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