2024-10-13 2024-10-13 , online online, 1,290 € zzgl. MwSt. Siniša Belina https://www.forum-institut.de/seminar/25062610-regulatory-lifecycle-management/referenten/25/25_06/25062610-course-regulatory-lifecycle-management_belina-sinia.jpg Regulatory Lifecycle Management

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.

Topics
  • Time and deadline management in the product lifecycle
  • Internal company interactions and coordination
  • Variations system and procedures
  • Electronic lifecycle management
  • Safety-related obligations and labelling


Who should attend
This seminar is intended for all involved in the post-approval activities and lifecycle management of human medicinal products, particularly those involved in regulatory affairs, pharmacovigilance and labelling.
Aims and objectives
This seminar provides a comprehensive overview of all maintenance activities in the lifecycle of a medicinal product.

Participants will receive thorough training on the main regulatory duties, from dossier update and variations to PV activities, through to labelling maintenance duties. All in a single seminar.

Time and deadline management, as well as internal company interactions and coordination will be covered, which makes the seminar interesting for professionals from the various departments involved in the product lifecycle.
Your benefit

  • All post-approval activities covered in a single seminar.
  • Comprehensive overview including in-depth knowledge provided by regulatory affairs experts.
  • Interactions between the PV, regulatory affairs and labelling departments in the course of the lifecycle will be addressed.

Course Regulatory Lifecycle-Management

Regulatory Lifecycle Management

Maintenance and sustainment of human medicinal product approvals

Benefits
  • Variations, labelling and PV - in a single course
  • Cooperation and time management
  • Bilingual speakers
  • An e-Learning can be booked
  • Officially certified to ISO 9001 and ISO 21001 standard

Webcode 25062610

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

04/06/2025

04/06/2025

Zeitraum

from 09:00 - 17:00
You may dial-in 30 minutes before

from 09:00 - 17:00
You may dial-in 30 minutes before
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Dr. Rebekka Bitsch
Conference Manager

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

Details

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.

Topics

  • Time and deadline management in the product lifecycle
  • Internal company interactions and coordination
  • Variations system and procedures
  • Electronic lifecycle management
  • Safety-related obligations and labelling


Who should attend
This seminar is intended for all involved in the post-approval activities and lifecycle management of human medicinal products, particularly those involved in regulatory affairs, pharmacovigilance and labelling.

Aims and objectives

This seminar provides a comprehensive overview of all maintenance activities in the lifecycle of a medicinal product.

Participants will receive thorough training on the main regulatory duties, from dossier update and variations to PV activities, through to labelling maintenance duties. All in a single seminar.

Time and deadline management, as well as internal company interactions and coordination will be covered, which makes the seminar interesting for professionals from the various departments involved in the product lifecycle.

Your benefit

  • All post-approval activities covered in a single seminar.
  • Comprehensive overview including in-depth knowledge provided by regulatory affairs experts.
  • Interactions between the PV, regulatory affairs and labelling departments in the course of the lifecycle will be addressed.

Detailed programme

from 09:00 - 17:00
You may dial-in 30 minutes before

Welcome, introduction and technical check


Dr. William Shang

Overview of lifecycle management
  • Time and deadline management
  • Internal company interactions and coordination
  • Change control and planning

Ingrid Prieschl

Variations system and procedures
  • Type IA/B and Type II variations
  • Notifications under Article 61(3)
  • Classification, with practical examples
  • Procedural issues and timelines
  • Grouping and work sharing

Coffee break


Siniša Belina

Electronic lifecycle management
  • The eCTD and eAF
  • European portals (CESP, PLM)
  • SPOR and IDMP

Lunch break


Dr. William Shang

Safety-related obligations
  • Management of labelling and product information changes
  • Implementation of PRAC decisions

Dr. William Shang

Regulatory product activities in the lifecycle
  • Rollout of approvals in other markets
  • Product reclassification (RX, OTC, etc.)

Coffee break


Ingrid Prieschl

Other post-approval activities
  • Renewals and referrals: Will they still be relevant in the future?
  • Other procedures following approval: Articles 45 and 46 of the Paediatric Regulation, transfer of marketing authorisation, post-authorisation measures, procedures for repeated use and change of RMS

Final questions and discussion


End of seminar


More information

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.

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. If you do not have access to the customer portal yet, you can easily register here.

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.

e-Learning: EU Variation System and Procedures

This e-Learning will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.

Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.

Please register for the seminar "Regulatory Lifecycle Management" by clicking '"Register" or "Buchen". You will receive a €100 discount if you also book the e-learning (you will be billed €390 + local VAT rather than €490 + local VAT).

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