2024-07-21 2024-07-21 , online online, 1,590 € zzgl. MwSt. Dr. Alexandra Günzl https://www.forum-institut.de/seminar/24092471-ctd-requirements-for-non-clinical-clinical-modules-and-ectd-readiness/referenten/24/24_09/24092471-seminar-ctd-requirements-for-non-clinicalclinical-data_guenzl-alexandra.jpg CTD: requirements for non-clinical/clinical modules and eCTD-readiness

Requirements for 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!

Topics
  • 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.
Aims and objectives
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.

Seminar  - CTD: requirements for non-clinical/clinical data

CTD: requirements for non-clinical/
clinical modules and eCTD readiness

- Online training -

Benefits
  • Tipps for study Reports + clinical expert report
  • Bibliographic CTD: specifics
  • Tools for practical implementation
  • Case studies + workshop
  • Officially certified according to ISO 9001 + 21001

Webcode 24092471

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

18-19/09/2024

18-19/09/2024

Zeitraum

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 starts

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 starts
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Requirements for 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!

Topics

  • 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.

Aims and objectives

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.

Detailed 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 starts

Welcome, introduction, expectations


Dr Alexandra Günzl

Introduction to the topic
  • 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

Non-clinical modules in the CTD
  • 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


Dr Sabrina Stöhr

Clinical modules in the CTD
  • 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

Bibliographic CTD
  • 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


Dr Kurt Eisinger

eCTD-readiness
  • eCTD basics
  • How to ensure eCTD-readiness of your documents

Dr Alexandra Günzl and Dr Sabrina Stöhr

Workshop
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.

Ende of the seminar


More informationen

In-house seminars: Training that fits!

Are you looking for this topic for several employees?
We offer the right solution on-site or in virtual format!

We also offer this seminar as an in-house seminar.
Use the tried-and-tested concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.


We would be happy to send you a non-binding offer.

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • 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.

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

Recommendations

Kennzeichnung, Verpackung und Marketing von Kosmetika

Erhalten Sie ein Update und einen umfassenden Überblick über den regulatorischen Rahmen der Kennzeichnung, Verpackung un...

09.10.2024, Online
Details

Verantwortliche Personen nach Art. 15 MDR

Erfahren Sie, was Sie in Ihrer Rolle als PRRC beachten müssen und welche Herausforderungen auf Sie warten. Dieses Online...

26.09.2024, Online
Details
Masterclass China: Medical Device Marketing Authorisation for Advanced

Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable i...

10. - 11.09.2024, Online
Details

Statistische Grundlagen klinischer Prüfungen

Möchten Sie wissen, wie man klinische Prüfungen statistisch valide plant und deren Ergebnisse statistisch sauber auswert...

16. - 18.09.2024, Online
Details

IITs und sonstige klinische Prüfungen mit Medizinprodukten

Nicht-kommerzielle und akademische, klinische Prüfungen mit Medizinprodukten - ein kompaktes Online-Seminar zur erfolgre...

12.09.2024, Online
Details

Go forward

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses.

Details
Our international course portfolio
e-Learning - Click and learn

We provide flexible education and training with high-quality e-Learning programmes for several topics.

Details
e-Learning
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

Details
We guarantee the highest quality