Introduzione

The rules governing veterinary medicinal products in the European Union (EU) establish standards and procedures to ensure proper regulation of these important products, both pre- and post-market entry. Prior to introducing any new veterinary medicinal product to the market, regulatory authorities conduct a thorough review to determine compliance with necessary standards. This process, known as the "Marketing Authorisation process," mandates that any new medicine is supported by a detailed data dossier that establishes the safety, quality and efficacy of a product.

The course will introduce you to the clinical and safety documentation (DACS - Detailed and Critical Summaries) required to support a veterinary marketing authorisation application in the EU.

  • Introduction to the structure of the MAA dossier for veterinary medicinal products
  • Specific documents: Detailed and Critical Summaries -DACS (Efficacy), DACS (Safety), User Risk Assessment (URA)
  • Practical part: gathering information and preparation of DACS documents with best practices and examples

Regulatory specialists, Veterinary Medical Advisors

Interactive training, discussion and practical approach.

Docente/i
Jana Brajdih Čendak
Info

Jana Brajdih Čendak

Medical and Pharmacovigilance Lead at Billev Pharma East

Jana started her professional career as a practicing physician, specializing in Emergency Medicine. After almost 10 years in clinical practice, she joined Sanofi’s Medical Affairs team, covering Southeast and Central European countries. Following a short transition to Novo Nordisk, she moved to Billev Pharma East, a consultancy company based in Slovenia. In her current position, Jana is responsible for a team of pharmacovigilance specialists, medical advisors, and veterinary medical advisors, covering human and veterinary pharmacovigilance and providing medical regulatory support to clients.
Her daily work involves preparation of MAA dossiers for human and veterinary medicinal products. She also acts as QPPV for human and veterinary products in the EU and UK.


Online Training – 1 module

30 October 2024 from 2:00 pm to 6:00 pm CET

Some days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 480,00* (until 09/10/2024)

Ordinary: € 610,00*

Freelance – Individual – Academy – Public Administration**: € 360,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the structure of the MAA dossier for veterinary medicinal products
Risultato atteso
Know the structure and content of the required clinical and safety-related documentation for a veterinary MAA
Risultato atteso
Understand the data requirements and assessment methodology required for preparing the DACS and URA
Risultato atteso
Prepare high-quality clinical documents to support a veterinary MAA

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>