QP-kurs og QP-oppfriskningskurs - NFS

QP-kurs og QP-oppfriskningskurs

 

Når kurset er aktuelt vil du se praktisk informasjon og påmelding i kurskalenderen.

 

 

Norsk Farmasøytisk Selskap tilbyr hvert annet år et 3 dagers QP-kurs og et QP-oppfriskningskurs (dagskurs) i Oslo i samarbeid med NSF Health Sciences (tidl. David Begg Associates) og Statens legemiddelverk. Se internettsiden til NSF Health Sciences. Kursene ble i stor grad avholdt på engelsk.

De neste kursene planlegges våren 2020.
Ta gjerne kontakt på post@nfs.no for mer informasjon.

 

QP-kurs


Kursdeltagere på QP-kurset, mai 2018

 

About the course

This interactive course provides an overview of the essential pharmaceutical laws and guidance for all persons working in the pharmaceutical industry. The course will focus mainly on EU and US FDA requirements but will include a half day dedicated to Norwegian requirements.

What you will learn:

  • Why medicines are regulated
  • An overview of medicinal product laws
  • Marketing Authorisations
  • The role and activities of the EMA
  • Regulations for Investigational medicinal Products
  • Manufacturing and Wholesale Authorisations
  • GDA Guidelines
  • The role of the QP
  • Regulatory controls for starting materials
  • Eudralex Volume 4: Good Manufacturing Practice
  • Complaints and recalls
  • Mutual Recognition Agreements
  • Data integrity
  • Pack Serialisation and Tracing

Who should attend?

This course will be of particular interest to personnel in QA or QC roles, and those aspiring to become QPs.

Kursholdere var Lynne Byers og Peter Gough fra NSF Health Sciences, i tillegg til Line Saxegaard fra Statens Legemiddelverk.

Kurset kvalifiserte til 17 FEVU-poeng (Farmasøytisk Etter- og VidereUtdanning).

 

QP-oppfriskningskurs


Kursdeltagere på QP-oppfriskningskurset, mai 2018

About the course

For individuals who already have a good understanding of pharmasceutical law and GMP (e.g. existing Qualified persons) a one day update, onrecebt changes to pharmaceutical legislation and guidance covering the following areas:

Pharmaceutical legislation and regulatory authority guidance is continually changing. These changes to legislation and guidelines, and the interpretation of them, can have significant implications for companies. Many changes require detailed planning to implement and failure to do so can result in serious compliance problems.

This is the continuation of a very successful series of one day seminars that are designed to form part of your Continuing Professional Development.

What you will learn:

The current interpretation recent and proposed changes to:

EU legislation:

  • Clinical Trial Regulation
  • New GMP legislation
  • New Medical Devices Regulation

EU GMP:

  • Revisions t Annexes 1 and 17 and new Annex 21

The potential impacts of the UK leaving the EU (Brexit)
ICH: new organization and draft of Q12
US legislation and FDA guidance

Who should attend?

Quality Assurance personnel, in particular Qualified Persons, who are already familiar with the basics of pharmaceutical legislation.
Other technical/managerial personnel responsible for the manufacture and testing of APIs and medicinal products.

 

Kursholdere var Lynne Byers og Peter Gough fra NSF Health Sciences, i tillegg til Line Saxegaard fra Statens Legemiddelverk.

Kurset kvalifiserte til 5 FEVU poeng (Farmasøytisk Etter- og VidereUtdanning).

 

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