Argenta recently hosted its 21st workshop on VICH good clinical practice (GCP) and efficacy studies in animals in the beautiful city of Munich. Attended by professionals from various countries and featuring speakers from European authorities and the University of Belgrade’s School of Medicine, the event aimed to provide a deep understanding and foster collaboration in ensuring the safety and effectiveness of veterinary medicinal products. At this workshop, we discussed strategies for navigating requirements for pre-clinical and clinical studies.

The workshop emphasised the importance of having a thorough and GCP-compliant approach at all stages of pre-clinical and clinical studies. Claudia Schneider, Head of Clinical Studies at Argenta Munich, was speaking on the important aspects to be considered when planning, conducting, and reporting clinical studies. She said: “Clinical studies should be compliant with established principles of GCP and applicable legislation and guidelines to assure regulatory approval.”

Dejan Cvejic, Head of Pre-Clinical Studies at Argenta Munich, delivered a presentation on pre-clinical efficacy studies. He highlighted: “Careful planning and the selection of experienced organisations and staff to work with are critical to project success.”

As part of the first day, participants engaged in practical workshops, where they developed study outlines for food-producing and companion animals, enhancing their practical understanding of the process. They enjoyed lively discussions, ideas exchange, and collaborative problem-solving. Miriam Rutz, Deputy Head of Clinical Studies at Argenta Munich, highlighted the practicality of such sessions, designed to address the complexity of the work environment and the challenges encountered in real life. The speakers emphasised the necessity of effective collaboration among stakeholders in overcoming challenges.

Throughout day two, the responsibilities in clinical studies and how to assure these are compliant and efficient were addressed. Miriam Rutz noted: “For example, the selection of investigators is crucial for the success of clinical studies. This decision not only impacts project success but also influences time-to-market and cost-effectiveness.”

Reflecting on their experience, our attendees shared: "Argenta’s workshop provided a comprehensive view of the clinical trial process and its particularities, from test permit applications to monitoring, quality assurance, veterinary products handling, and distribution. The practical approach and the insights of the new legislations were interesting, as well as the external speaker presentations that gave us the statistical and the authorities’ point of view on clinical trials. The hands-on approach of the workshop made it very dynamic and meeting other participants and the Argenta team was very enriching and helpful in terms of networking.”

Overall, the workshop provided invaluable insights and practical knowledge for professionals involved in designing clinical studies, ensuring regulatory compliance, and strategising for animal health products. The necessity of selecting trustworthy partners and ensuring well-trained study personnel are crucial for avoiding delays and maintaining data integrity.

The workshop's relevance extended to various stakeholders, including R&D departments in veterinary pharmaceutical companies, regulatory affairs teams, government agencies, and specialised consultants. “I would recommend this course to anyone working in the field of veterinary drug development. It was a great experience!” said attendee Pablo.

“Tactical approaches within the regulatory environment are critical to the performance of clinical studies. With Argenta's track record, experience, expertise, and global network, we are well positioned to help the industry effectively,” said Didier Peoc'h, General Manager, Argenta Munich.

If you are interested in participating in the 2025 workshop on VICH GCP and efficacy studies in animals, please register your interest and we will keep you posted about early bird registration opportunities.

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