Training on Good distribution Practice (GDP)

  • 2° EDITION: 23 May 2024
  • Online
  • Italian

Training overview

This training course on Good Distribution Practice (GDP) will explain you the European and local regulatory environment for the distribution and marketing of medicinal products. The training will examine the application of the November 5 2013, Guidelines on Good Distribution Practice (GDP) of medicinal products for human use (2013/C 343/01), which establish the appropriate tools to assist wholesale distributors in carrying out their activities; these activities are carried out with manufacturers or their depositories.

Key points of the training

  • Regulatory framework for product distribution and marketing
  • GMP and GDP: general concepts
  • Focus on Good Distribution Practice (GDP) of medicinal products
  • Pharmaceutical transportation and safety aspects: measures to combat pharmaceutical crime
  • Drug traceability
  • The responsibility of the various actors in the drug supply chain

09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

  • Regulatory framework and guidelines for medicinal products distribution and marketing
  • GMP and GDP: general concepts
  • The responsibility of the various actors in the drug supply chain
  • Drug traceability
  • Pharmaceutical transportation and safety aspects: measures to combat pharmaceutical crime
  • Focus on Good Distribution Practice (GDP) of medicinal products:
  • Quality Management
  • Personnel and training
  • Documentation
  • Premises and Equipment and Operations: receipt and storage
  • Complaints, returns, suspicions about falsified medicines, and medicine recalls
  • Outsourced activities
  • Self-inspections
  • Broker
  • Q&A time

Quality Assurance, Regulatory, Supply Chain and Logistics.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

Speakers

Paola Scavo

Paola Scavo

Process & Quality - Team Leader Senior Consultant at Pharma D&S

She graduated in Pharmaceutical Chemistry and Technology in Pisa, she has been working in Pharma D&S since 2014, where today she holds the role of Process & Quality Senior Consultant – Team Leader. She deals with the development of Quality Systems in the pharmaceutical and medical device fields and with Quality operational support for carrying out the maintenance activities of the Quality Systems for Marketing Authorization Holders/affiliates of multinationals, according to the applicable local legislation, the GMP/GDP/ GVP, the ISO 9001, ISO 13485 standards and the Farmindustria guidelines.

Register now

Early Bird 10%
Within 2 months before the start of the training
720€
800€
Early Bird 5%
Within 1 month before the start of the training
760€
800€
Full price

800€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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