Introduzione

According to the EMA, "Good Distribution Practice (GDP) describes the minimum standards that a wholesaler must meet to ensure that the quality and integrity of medicinal products is maintained throughout the supply chain".

This course will provide an understanding of the key aspects of GDP for pharmaceutical manufacturers, wholesalers, logistics companies and distributors of veterinary medicines. You will gain an understanding of the key aspects of GDP for the pharmaceutical industry and how to maintain compliance in the distribution of pharmaceutical products.

The course is designed to provide you with a general knowledge of pharmaceutical GDP, the regulatory environment and its impact throughout the marketing authorisation, distribution and life cycle of pharmaceutical products. Practical activities throughout the day will give you the opportunity to raise awareness of the GDP Guideline and gain an overview of pharmaceutical GDP regulators and best practices, so that the knowledge gained can be applied in the workplace on completion of the course.

  • Introduction and background
  • The GDP Quality Management System (QMS)
  • Personnel
  • Premises and equipment
  • Documentation
  • Operations
  • Complaints, return, suspected falsified medical products and product recall
  • Outsourced activities
  • Self-inspections
  • Transportation
  • Course review and summary
  • Reflection and feedback
  • Close of day

The course is ideal for anyone in a role within an organization that distributes pharmaceutical medicines, this may involve quality assurance, procurement, sales, logistics supply chains, including warehousing, transportation, distribution, or wholesalers.

 

Participant’s experience
There are no formal prerequisites for this course, but it would be advantageous to have some previous experience within the pharmaceutical supply-chain.

Presentation and workshop exercises.

Docente/i
Sebastjan Reven
Info

Sebastjan Reven

Managing director, QP/RP at Billev Pharma East

Sebastjan has a PhD in Pharmaceutical Technology and almost 20 years of experience in the field of pharmaceutical industry and manufacturing of medical devices, including in the field of research and development, quality assurance and batch release of medicinal products and medical devices in a global pharmaceutical company.

In addition, his previous experience as acting as a Head of Pharmaceutical Inspection division at national competent authorities and being responsible for coordinating, organizing and leading over 30 employees within Division (GMDP, GCP, MD, PhV, blood, tissues and cells) has offered him a considerable knowledge of the pharmaceutical and medical device regulation and legislation as well as experience in supervision of the implementation of good practices and regulation in the pharmaceutical and medical device industry. He was also a member of several European Institutions defining future directions of Regulatory Bodies.

Currently he is acting as a managing director and is responsible for supervision of all company’s operations and people to develop and execute business strategies to achieve short and long-term company’s goals.


Online Training – 1 module

17 September 2024 from 2:00 pm to 6:00 pm CEST

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 27/08/2024)

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.

Francesca Archetti
Francesca Archetti
Marketing & Sales Specialist
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Describe the distribution chain and common related issues
Risultato atteso
Direct pharmaceutical product, compliance and commercial impacts from poor distribution practices
Risultato atteso
Describe pharmaceutical Good Distribution practice (GDP)

<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>