2024-12-21 2024-12-21 , 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

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