2024-04-24 2024-04-24 , online online, 1,190 € zzgl. MwSt. Gabriele Eibenstein M.A. https://www.forum-institut.de/seminar/24062610-eu-regulatory-affairs-introductory-training-course/referenten/24/24_06/24062610-flexible-booking-options-according-to-your-needs_eibenstein-ma-gabriele.jpg EU Regulatory Affairs Introductory Training Course

Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on all important issues. The training course will be entirely held in English.

Topics
  • Day 1: Marketing Authorisation procedures in Europe: Legal basis, mutual recognition, decentralised and centralised procedure in detail
  • Day 2: Marketing Authorisation documents: Data for the dossier, key elements and structure of the SmPC and the package leaflet
  • Day 3: Regulatory lifecycle management: Variations, renewals, eCTD and electronic submission


Who should attend
This seminar will be of benefit to all those working in regulatory affairs or in related departments that need essential European regulatory affairs expertise. Basic pharmaceutical knowledge is recommended but not prerequisite.
Aims and objectives
This online introductory training course will inform you about all the important obligations and challenges in regulatory affairs.

You will learn about the different procedures in Europe and about the data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory lifecycle management for a product and the structure and submission of an electronic dossier.

Book day 1, day 1 and 2 or all three days, according to your needs! A preparatory e-Learning is included in your booking.
Your benefit

In this seminar you will

  • get to know the basic principles for MA procedures in Europe
  • learn about the different procedures in detail
  • know what to have in mind for SmPC and the package leaflet
  • learn about the different modules of the dossier
  • get to know the Variation system and procedures
  • get to know all you need about the electronic submission
  • learn with many practical examples

seminar-pharma-eu-regulatory-affairs-introductory-training-course

EU Regulatory Affairs Introductory Training Course

3-day workshop for beginners in EU drug regulatory affairs

Benefits
  • EU drug regulatory affairs for beginners
  • Individual booking options according to your needs
  • Online format: Flexible, modern, interactive
  • We are following the IMI quality criteria

Webcode 24062610

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

05-07/06/2024

05-07/06/2024

Zeitraum

Day 1: 09:00 - 17:00
Day 2: 09:00 - 17:00
Day 3: 09:00 - 17:00

Day 1: 09:00 - 17:00
Day 2: 09:00 - 17:00
Day 3: 09:00 - 17:00
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Rebekka Bitsch
Conference Manager

+49 6221 500-565
r.bitsch@forum-institut.de

Details

Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on all important issues. The training course will be entirely held in English.

Topics

  • Day 1: Marketing Authorisation procedures in Europe: Legal basis, mutual recognition, decentralised and centralised procedure in detail
  • Day 2: Marketing Authorisation documents: Data for the dossier, key elements and structure of the SmPC and the package leaflet
  • Day 3: Regulatory lifecycle management: Variations, renewals, eCTD and electronic submission


Who should attend
This seminar will be of benefit to all those working in regulatory affairs or in related departments that need essential European regulatory affairs expertise. Basic pharmaceutical knowledge is recommended but not prerequisite.

Aims and objectives

This online introductory training course will inform you about all the important obligations and challenges in regulatory affairs.

You will learn about the different procedures in Europe and about the data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory lifecycle management for a product and the structure and submission of an electronic dossier.

Book day 1, day 1 and 2 or all three days, according to your needs! A preparatory e-Learning is included in your booking.

Your benefit

In this seminar you will

  • get to know the basic principles for MA procedures in Europe
  • learn about the different procedures in detail
  • know what to have in mind for SmPC and the package leaflet
  • learn about the different modules of the dossier
  • get to know the Variation system and procedures
  • get to know all you need about the electronic submission
  • learn with many practical examples

Detailed programme

Day 1: 09:00 - 17:00
Day 2: 09:00 - 17:00
Day 3: 09:00 - 17:00

09:00 - 17:00 Workshop 1: Basic principles of drug regulatory affairs


09:00 - 09:15 Welcoming and introduction round


09:15

Dr. Christian M. Moers

Basic principles and terminology
  • The regulatory framework: regulations, directives and guidelines
  • Involved authorities
  • The available marketing authorisation procedures: centralised, decentralised and national
  • Role of the coordination group (CMDh)

10:30 Coffee break


10:45

Dr. Christian M. Moers

Legal basis for marketing authorisation procedures in Europe
  • Full application, bibliographic application, mixed application, and informed consent
  • Generic application, hybrid application and biosimilars
  • Registration

12:00 Lunch break


13:00

Gabriele Eibenstein M.A.

Mutual recognition and decentralised procedures
  • Common principles
  • Submission strategy
  • Deadlines and clock stops

14:15

Gabriele Eibenstein M.A.

Centralised procedure
  • Scope and mandatory products
  • Role of the EMA and committees, e.g. CHMP
  • The procedure in detail
  • Scientific advice
  • Challenges for innovative products

15:45 Coffee break


16:00

Dr. Christian M. Moers

Specifics for generics
  • Data exclusivity and innovation protection
  • European reference product

16:45 Q&As Day 1


17:00 End of Day 1


09:00 - 17:00 Workshop 2: Marketing Authorisation Documents


09:00 Welcoming and introduction round


09:15

Émanuela Negri

Early Access of medicinal products to patients
  • Compassionate Use
  • Specifics for Support Mechanism: PRIME, Scientific Advice and Accelerated Assessment
  • Specifics for Authorization: Conditional Approval, Exceptional Approval

10:15

Émanuela Negri

Marketing authorisation dossier - Module 1
  • Overview of the CTD: purpose and structure
  • Module 1 Specification
  • Focus on the cover letter and application form
  • National peculiarities

11:15 Coffee break


11:30

Émanuela Negri

SmPC and the package leaflet
  • Key elements and structure of the SmPC and the package leaflet
  • QRD templates

12:30 Lunch break


13:15

Émanuela Negri

Module 2
  • Common principles for overviews and summaries

14:45

Dr.ssa Ida Caramazza

Nonclinical data: Module 4, nonclinical summaries and nonclinical overview
  • Compilation of preclinical dataPharmacologyPharmacokineticsToxicologySmPC consistency with nonclinical data
  • Common errors and authority findings

15:40 Coffee break


15:50

Dr.ssa Ida Caramazza

Clinical data: Module 5, clinical summaries and clinical overview
  • Compilation of clinical dataBiopharmaceuticsClinical pharmacology
    • Efficacy
    • Safety
    • Benefit and risk conclusions
  • Benefit and risk conclusions
  • SmPC consistency with clinical data
  • Common errors and authority findings

16:50 Q&As Day 2


17:00 End of Day 2


09:00 - 17:00 Workshop 3: Regulatory Life Cycle Management


09:00

Ingrid Prieschl

Variation system and procedures
  • Variation Regulation, Classification Guideline
  • Type IA/B notifications and Type II variations: Correct classification
  • Classification with practical examples
  • Extension of Marketing Authorisations

10:45 Coffee break


11:00

Ingrid Prieschl

Post-approval activities
  • Renewals
  • Referral procedures
  • Pharmacovigilance duties:
    • PSURs, Risk Management Plans
    • PASS/PAES, Signal Management Procedure
  • Further post-authorisation procedures: Article 45, 46 of paediatric regulation, MA transfer, post-authorisation measures, repeat-use procedure, change of RMS

12:30 Lunch break


13:30

Karl-Heinz Loebel

eCTD/electronic submission of application documentation
  • eCTD basic principles: Structure, document requirements and dossier lifecycle
  • EU Module 1 eCTD requirements
  • eCTD specifics for centralised, decentralised and purely national applications
  • CESP Portal and EMA axway/syncplicity gateway
  • Outlook: eCTD 4.0/Next Major Version

15:00 Coffee break


15:15

Karl-Heinz Loebel

Data submission and technology changes
  • Unstructured - semi-structured - structured information
  • EMA IT Product Portfolio
  • EMA access and user account management
  • electronic Application Forms - PLM portal
  • from XEVMPD to SPOR
  • IRIS and CTIS

16:50 Q&As Day 3


17:00 End of Seminar


Workshops

Day 1: Basic principles of drug regulatory affairs

June 05, 2024


Dr Christian M Moers, Gabriele Eibenstein
Day 2: Marketing Authorisation Documents

June 06, 2024


Emanuela Negri, Dr Ida Caramazza
Day 3: Regulatory Life Cycle Management

June 07, 2024


Ingrid Prieschl, Karl-Heinz Loebel

More information

Access to and procedure for online events

Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

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

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

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