Managing the interface between Quality and Regulatory Affairs (RA)
Webcode 26072452
Raimund Brett
gempex GmbH, Mannheim, GERMANY
Principal Consultant
Raimund Brett is a certified industrial master craftsman specialising in pharmacy (IHK) and has worked in the manufacture of sterile drugs and the galenic development of oral drug forms.
Other positions include shift management at a production facility for solid oral dosage forms, operations management at a packaging plant, and GMP management and quality assurance management at a CMO of an equipment manufacturer. He also gained experience in outsourcing clinical trial samples, managing the production of sterile trial samples, and as an auditor for a manufacturer of vaccines and diagnostics.
In 2015, he moved into consulting. Since then, he has been advising clients on compliance issues for quality assurance systems in the areas of small molecule and biological drugs (including ATMPs) as well as combination products (medical devices plus drugs).
He has been a principal consultant at gempex GmbH since 2020.
More information please click here.
Dr. Rainer Ilg
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, GERMANY
Senior Associate Director, Global Technical Regulatory Affairs Dr Ilg has been working at Boehringer Ingelheim since 2007. He spent his first few years in analytical development before moving to CMC Regulatory Affairs for small molecules in 2009. Since 2013, he has been working in the biopharmaceutical division of the company, where he acts as team leader at the interface between various specialist disciplines and regulatory functions. In this role, he and his team also provide regulatory support for the development and life cycle of customer products manufactured at Boehringer Ingelheim.
Dr. Ralph Nussbaum
Omega Pharma Manufacturing GmbH & Co KG, Herrenberg, GERMANY
Head Quality & Qualified Person
Dr Nussbaum has been Head of Quality & Qualified Person at Omega Pharma Manufacturing GmbH & Co KG since August 2024.
Over the past 30 years, he has held senior QC/QA positions at various pharmaceutical companies, including AuregenBiotherapeutics, Synlab, Analytical Services, Carbogen-Amcis, and Grünenthal.
His areas of expertise include analytical method development, method validation and transfer, and equipment qualification.
Dr Nussbaum has been a speaker in these fields for many years.
More information please click here.
03/07/2026
03/07/2026
Online seminar from 9:00 am until 5:00 pm CET
You may dial in 30 minutes before the lecture starts
online
online
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Quality & GMP Essentials for Regulatory Affairs/CMC: Managing the interface - knowledge of quality-relevant facts, GMP fundamentals, as well as understanding of the processes at the interface - including an Update on various guideline revisions, e.g. ICH Q1, M4Q(R2) and more - Qualify now!
As an employee in Regulatory Affairs/CMC, do you want to master collaboration and communication at the interface with the quality department in a confident, efficient, and sustainable manner?
Essential for this is knowledge of quality-relevant facts, GMP fundamentals, as well as understanding of the processes at the interface.
After participating in the seminar, you will have gained insight into the requirements and workflows in the GMP-regulated area. Your understanding of the daily challenges faced by the quality department will be enhanced. You will know the data basis for your CMC documents and will have discussed approaches for transferring this knowledge to the regulatory area.
Realistic examples will strengthen the implementation of efficient communication at the interface between Quality and Regulatory Affairs/CMC in your daily work.
What can you expect from the seminar content?
Here are some comments from former participants:
Welcome, introduction, expectations
Raimund Brett and Dr Rainer Ilg
Bio break
Dr Ralph Nussbaum
Lunch break
Raimund Brett
Dr Ralph Nussbaum
Bio break
Dr Rainer Ilg
All speakers
Recap and outstanding questions
End of seminar
This seminar is the basic module of our qualification programme "CMC-Specialist".
The course concept:
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