BioM Workshop: Get ready for the clinic 2025
Are you ready to navigate the path from early nonclinical development to your first-in-human clinical trial?
Join us for an exclusive workshop that will guide you through the journey from early nonclinical development to your first-in-human clinical trial! Learn how to avoid common development pitfalls and meet key regulatory expectations. Gain practical insights and hands-on knowledge from leading industry experts.
Date: Thursday, 11 December 2025
Time: 9.00 A.M. - 4.30 P.M.
Location: BioM Conference Room "München", 3rd floor, Am Klopferspitz 19a, 82152 Martinsried
! Limited seats available – register now!
(Registration form at the bottom of the page)
Are you ready to navigate the path from early nonclinical development to your first-in-human clinical trial? Do you know how to steer clear of common development pitfalls and meet key regulatory expectations?
- Introduction: Target Product Profile, Development Plan, Regulatory Strategy
- Manufacturing authorization and Good Manufacturing Practice
- Quality of investigational drugs
- From research into clinic: Nonclinical drug development
- Authority Interaction Strategy
Learning Objective
The workshop conveys the relevant regulatory fundamentals and deepens the acquired knowledge through practical case studies.
Target Audience
The workshop is aimed at professionals working in manufacturing, Nonclinical, Clinical, Project Management and Regulatory Affairs who are involved in the development of investigational medicinal products.
About the Company
Granzer Regulatory Consulting & Services offers support in all phases of drug and device development. From defining the right development strategy to submitting your marketing authorisation application, all the way through to approval and beyond.
We take great pride in supporting our clients with pioneering, innovative, and ambitious strategies. Our track record speaks for itself, as we have been first in the development of peptide-based vaccines, mRNA technologies, CAR-T therapies, CRISPR/Cas advancements, and the first marketing authorisation of a COVID-19 vaccine.
Meet the Speakers
Kirsten Vonde, Executive Consultant, Expert for Clinical & Regulatory Strategy
Kirsten Vonde has extensive experience in developing global regulatory strategies for medicinal products, medical devices, and in-vitro/companion diagnostics. She specializes in the preparation and submission of Marketing Authorization Applications (MAA), New Drug Applications (NDA), as well as Clinical Trial and Investigational New Drug Applications, including related maintenance activities. Additionally, she coordinates scientific advice meetings with European authorities and the FDA, prepares briefing packages, and manages submissions for Paediatric Investigation Plans and Orphan Designation Requests. Her expertise also includes CE certifications for medical devices and establishing and maintaining quality assurance systems in pharmaceutical distribution companies.
Dr. Robert Zoubek, Executive Consultant, CMC Expert
Robert Zoubek has more than 20 years of experience in the development of pharmaceuticals. He joined Granzer Regulatory Consulting & Services GmbH in October 2013 and supports clients in all questions concerning regulatory affairs, drug substance and drug product development, manufacturing, quality control, comparability and analytics. He has in depth knowledge in European and US procedures with IMPD/ IND, MAA and BLA. Robert´s expertise covers gene therapy, cell therapy, advanced therapeutic medical products, multiple types of vaccines, peptides and recombinant proteins.
Dr. Thorsten Meyer, Executive Consultant, Nonclinical Expert
Thorsten Meyer holds a PhD in biochemistry/immunology from the University of Hannover and is a European registered toxicologist (ERT). He has been working for more than 20 years in pharmaceutical industry and has supported development of more than 300 development candidates (small molecules, monoclonal antibodies, protein, bi-specific products, ATMPs, anti-sense oligos and vaccines) in a wide spectrum of therapeutic indications. As part of his role as an executive consultant at Granzer Regulatory Consulting & Services GmbH, he is supporting pharmaceutical companies in the development and regulatory authority interactions for new chemical entities (NCE), new biological entities (NBE) as well as ATMPs (covering cell, gene and tissue therapies) in the EU, North America and UK.
More information regarding the programme you can find in our agenda.
Registration & Workshop Details
Participation fee: including meals and seminar materials
200 € (plus VAT) for academia
300 € (plus VAT) for industry
Please also note our cancellation deadlines according to our GTC.
Certificate of participation:
All participants will receive a certificate at the end of the workshop.
Secure your spot now and stay ahead!
The number of participants is deliberately limited to enable intensive exchange. Secure your place by registering electronically using the registration form below. Select the “ticket” you require and confirm with a click.
The registration deadline is extended until Monday, 1 December 2025!
If you have any questions, please contact our event team at events@bio-m.org.