Beschreibung

IPEC Europe and APV are delighted to invite you to our 12th annual conference on pharmaceutical excipients slated on 24-25 September 2024 in Vienna, Austria.
The conference will be held on two days: from Tuesday (morning) until Wednesday (evening) and will focus on regulatory topics relating to pharmaceutical excipients and technology.
The day one will focus on regulatory topics, and we will offer five presentations and three “workshops”. We will open the conference with a presentation on IPEC Federation, followed by a talk on Pharmacopeia matters from EDQM. The remaining of the presentations will cover current critical topics like excipients quality, composition & impurities, excipient taxonomy for the 21st century, and an approach to computerized system validation.
The regulatory workshops aim to provide detailed practical information about current topics supporting industry to comply with regulatory requirements and other expectation. These “workshops” will be held two times in parallel to allow participants to attend two of the three sessions. These sessions will allow practical exercises and discussions related to the topics covered. Participants will have the opportunity to exchanges their personal experience with colleagues out of the same industrial and regula¬tory environment. The workshop topics will be on, 1- New IPEC federation GDP Guideline, 2- Change control guidelines, and 3- How to provide regulatory information for excipients.
Since excipients are key parts of the formulation of medicines, we will open the second day with a presentation on data integrity. Afterwards, we will take the opportunity to listen to a variety of subjects such as excipients selection for soft capsules product development, and innovative approach for taste masking to enhance patient compliance. This year, we will have a stronger focus on biologics with three (3) topics: digitalization of biologics manufacturing process, stabilizer for Biopharmaceuticals, and new approaches for drug delivery utilising extracellular vesicles.

Zielgruppe

This conference is aimed at professionals working in the following areas:
Development, production and quality
Distribution and sales
Qualification of suppliers
Application and control of pharmaceutical excipients for medicinal products
The seminar is also aimed at employees of regulatory authorities and purchasing departments.

Zielsetzung

The primary goal of the conference is to highlight current hot topics in the field of pharmaceutical excipients.
Take this opportunity to share your experiences and discuss with colleagues of pharmaceutical industry, academics, authorities as well as with manufacturer and distributors of pharmaceutical excipients.
This year again, you will be able to choose two out of three workshops on the first day:

• New IPEC Federation GDP Guideline
• Change Control Guideline
• How to provide Regulatory Information for Excipients: from both sides - from the user‘s perspective and from the manufacturer‘s perspective

Further hot topics of the conference in this year will be:

• EDQM update on pharmacopeial matters.
• Excipients: USP focus and update on quality, composition, and impurities.
• Excipient taxonomy for the 21st century.
• An approach to computerized system validation.
• Excipient selection in soft capsule product development.
• Enhancing patient compliance: Innovative approaches of taste masking.
• Digitalization for manufacturing process development of biologics drug product (fill & finish).
• Stable stabilizer for biopharmaceuticals.
• Exogenous loading of extracellular vesicles.