2024-12-28 2024-12-28 , online online, 1,290 € zzgl. MwSt. Prof Everaldo Attard https://forum-institut.de/seminar/25112450-hot-topics-related-to-quality-in-herbal-medicinal-products/referenten/25/25_11/25112450-hot-topics-related-to-quality-in-herbal-medicinal-products_attard-everaldo.jpg Hot Topics Related to Quality in Herbal Medicinal Products

Experts from national competent authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline), the changes of procedures and corresponding chances (MRP/DCP), and the use and "impact" of new evaluation methods (Real World Data). The authority's prespective is complemented by industry's experiences.

Topics
  • The Pharma-Package
  • MRP/DCP: An overview and outlook
  • EFSA/ECHA: "One substance, one assessment"
  • Revision "Variation Regulation" and "Variation Classification Guideline"
  • Revised GACP Guideline
  • Use and "impact" of Real Word Data


Who should attend
This conference addresses the needs of all those working with herbal medicinal products in the various European markets, especially those dealing with quality and regulatory affairs issues.
Aims and objectives
Dealing with herbal medicinal products poses many challenges related to quality.
Experts from different national competent authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline), the changes of procedures and corresponding chances (MRP/DCP), and the use and "impact" of new evaluation methods (Real World Data). The authority's prespective is complemented by industry's experiences.

This conference will leave you with a better understanding of national competent authorities' current understanding of quality and upcoming trends related to quality.
Your benefit

Here are some voices of the last event in 2023 (biennial event):

  • "I am very thankful for all the input during the day and it was all I expected from the beginning."
  • "I received the lates news and details especially from the speakers from Sweden and Switzerland."
  • "I received all the informations she needed."

Hot Topics Related to Quality in Herbal Medicinal Products

Hot Topics Related to Quality in Herbal Medicinal Products

- Authority's prespective and industry's experiences -

Benefits
  • Authority's perspective and industry's experiences
  • Revision of "Variation Guideline"
  • Experts from Sweden, Austria, Malta, Germany
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25112450

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

27/11/2025

27/11/2025

Zeitraum

09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts

09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

Experts from national competent authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline), the changes of procedures and corresponding chances (MRP/DCP), and the use and "impact" of new evaluation methods (Real World Data). The authority's prespective is complemented by industry's experiences.

Topics

  • The Pharma-Package
  • MRP/DCP: An overview and outlook
  • EFSA/ECHA: "One substance, one assessment"
  • Revision "Variation Regulation" and "Variation Classification Guideline"
  • Revised GACP Guideline
  • Use and "impact" of Real Word Data


Who should attend
This conference addresses the needs of all those working with herbal medicinal products in the various European markets, especially those dealing with quality and regulatory affairs issues.

Aims and objectives

Dealing with herbal medicinal products poses many challenges related to quality.
Experts from different national competent authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline), the changes of procedures and corresponding chances (MRP/DCP), and the use and "impact" of new evaluation methods (Real World Data). The authority's prespective is complemented by industry's experiences.

This conference will leave you with a better understanding of national competent authorities' current understanding of quality and upcoming trends related to quality.

Your benefit

Here are some voices of the last event in 2023 (biennial event):

  • "I am very thankful for all the input during the day and it was all I expected from the beginning."
  • "I received the lates news and details especially from the speakers from Sweden and Switzerland."
  • "I received all the informations she needed."

Detailed programme

09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts

Welcome, introduction, expectations


Dr Erika Svedlund and Dr Bernd Roether

The Pharma-Package: Authorities' and industries' point of view
  • Proposed changes and the possible impact on the field of herbal medicinal product
  • Impact on documentation for MA, promotion, marketing-related activities (health-related claims)

Bio break


Dr Astrid Obmann

MRP/DCP: An overview and outlook

Dr Hartwig Sievers or Anke Steuber

EFSA/ECHA: "One substance, one assessment"
  • Impact on maintenance (change of existing formulations), stability studies, method development/-validation, change management, R&D

Lunch break


Dr Friederike Stolte

Revision "Variation Regulation" and "Variation Classification Guideline" - relevance for phytopharmaceuticals

Bio break


Dr Nico Symma and Prof Everaldo Attard

Revised GACP Guideline

Dr Jacqueline Wiesner

Use and "impact" of Real Word Data
  • RWD as a component for marketing authorisation/registration applications or monographs from the HMPC: possibilities and limitations

Recap and outstanding questions


End of seminar


More information

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

APIs in Regulatory Affairs

Sie sind Fachkraft in der pharmazeutischen Industrie im Bereich Zulassung und verantworten die Zusammenstellung der Qual...

19. - 20.02.2025, Online
Details

CMC Writing

You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with...

18.02.2025, Online
Details

Qualitätsbedingte Variations

Welche Änderung in Analytik und Herstellung bedingt welchen Typ Änderungsanzeige? Online-Seminar zur Klassifizierung und...

29. - 30.01.2025, Online
Details

EU-Arzneimittelzulassung für Einsteiger*innen

In diesem Seminar erhalten Sie Know-how zur Zulassung von Arzneimitteln in Europa. Sie lernen, welche Zulassungswege mög...

21. - 24.01.2025, Online
Details

e-Learning: GMP für das non-GMP Umfeld

Verschaffen Sie sich GMP-Grundwissen zu den Anforderungen und der Umsetzung der Guten Herstellungspraxis in Europa.

31.12.2024, Online
Details

Go forward

DEMO-Account e-Learning

Try out our e-Learning programmes free of charge and without any obligation.

Details
DEMO-Account e-Learning
e-Learning - Click and learn

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

Details
e-Learning
Our rating in 2023

More than 4,500 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.

Details
Our rating in 2023