Date and location

3 October 2024

Hybrid (Online & In-person (EDQM premises, Strasbourg)

English

INTRODUCTION

In 2021, PDG launched a pilot programme inviting other world pharmacopoeias to join the existing panel of members in developing robust, science-based, harmonised pharmacopoeial standards. Last year, the Indian Pharmacopoeia Commission (IPC) joined as the PDG’s fourth member. This new collaboration provided invaluable insights and laid the foundations for a new global initiative. Additionally, the PDG led the maintenance of the ICH Q4B guideline and its 16 annexes, involving 9 global pharmacopoeias in the harmonisation of these critical texts. Entrusted with this task by the International Council for Harmonisation (ICH), the purpose of this guideline and its annexes is to achieve regulatory interchangeability among 15 regulatory authorities.

To date, the PDG has successfully harmonised and maintains 31 general texts, including key analytical procedures such as chromatography, dissolution testing, sterility, and microbiological examination. Its achievements have also included the harmonisation of 48 excipient monographs, with a further 20 or so new texts in the pipeline. The PDG remains dedicated to promoting the recognition of harmonised pharmacopeial standards to achieve global convergence.

PROGRAMME OVERVIEW

This event offers a unique interactive opportunity to engage with representatives from four global pharmacopoeias, i.e. the Ph. Eur., IPC, JP, and USP. Participants will have the opportunity to hear about and discuss the latest milestones achieved by the PDG.

Key topics to be discussed include:

  • Feedback on the PDG’s expansion pilot: celebrating the successful inclusion of the Indian Pharmacopoeia Commission (IPC) as the fourth member in October 2023.
  • Future expansion plans: updates on the next steps and further programmes for the PDG’s expansion, including lessons learned from the pilot phase and outreach to additional global pharmacopoeias.
  • ICH Q4B(R1) background: insights into the new ICH Q4B(R1) guideline, developed by the PDG with the involvement of 9 global pharmacopoeias focussing on harmonising 16 annexes.
  • Technical challenges: discussion on the technical challenges encountered by the PDG in the harmonisation process.
  • Collaboration opportunities: how to collaborate with the PDG and support the harmonisation of excipient monographs and general texts, including anticipated developments in the PDG’s interaction with stakeholders.

This unique event will feature ample opportunities for questions and interactive discussions. To ensure the best experience, we encourage in-person participation, so register quickly to reserve your place!

The event will take place on 3 October 2024, from 9:00 to 13:00 (CEST, France).

Download the programme

WHO SHOULD ATTEND?

This event will appeal to professionals from the pharmaceutical industry, including pharmacopoeial and regulatory affairs staff, laboratory scientists and QC managers. It will also be of interest to those involved in harmonisation across regions.

Participation is free of charge.

REGISTRATION FEES

This event is free of charge. Places are limited, so sign up today!
Each registered participant will receive a copy of the presentation slides and the link to the event recording which they can refer to if needed in the future.

HOW TO REGISTER

IN-PERSON PARTICIPATION (EDQM premises, 7 allée Kastner, Strasbourg, France)

REGISTER HERE

ONLINE PARTICIPATION

REGISTER HERE


After registration you will receive an invitation telling you how to access the event and how to test the system beforehand. On the day of the event, click on the link in the registration confirmation email.

You can also check your system’s compatibility automatically.

Before registering, please read the Terms of Supply for EDQM Events.

ADDITIONAL INFORMATION
Technical requirements
Help