Pharmaceutical Law and Administration Training

NSF, Health Sciences
Übersicht
5 Tage
Englisch
Kurse
NSF, Health Sciences

Beschreibung

Pharmaceutical Law and Administration Training

About This Course

Pharmaceutical law and administration are key foundation knowledge requirements for all QPs. This is clearly spelled out in the relevant article of European Directives 2001/82/EC and 2001/83/EC and in the current Qualified Person Study Guide. Our highly interactive, four-and-a-half-day training course is designed to provide aspiring QPs and pharmaceutical quality professionals with the understanding of international pharmaceutical legislation that is needed to carry out their duties with skill and authority.

Beyond understanding, the QP and other pharmaceutical technical managers must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within the UK, Europe and beyond, is essential.

Subjects Covered

  • Pharmaceutical legislation
  • Regulations and guidance that dictate how we must work on a daily basis
  • Why these laws exist and how they come into being
  • Roles and responsibilities of the major international regulatory agencies
  • The key role that QPs and pharmaceutical professionals must play to ensure compliance with international legislation in the interest of patient safety

If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

This course is approved by the Royal Society of Chemistry and is suitable for its members’ continuing professional development.

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Inhalte / Module

Course Outline

European Medicines Legislation

  • The legislative framework in the EU
  • EU directives and regulations affecting medicines
  • Laws governing clinical trials and investigational medicinal products
  • Organization and function of EMA
  • EU GMP (EudraLex Volume 4)
  • EU marketing authorisation, content, structure (CTD) and application routes
  • Variations to marketing authorizations
  • Non-clinical data/toxicology
  • Importation into the EU and distribution within the EU
  • Powers of the licensing authorities and sanctions that can be imposed
  • Pharmacovigilance

Manufacturing and Wholesale Authorizations

  • Starting material controls
  • Parallel imports
  • Controlled drugs

UK Medicines Legislation

  • Background and development of UK medicines legislation
  • MHRA and VMD
  • Current expectations for the UK leaving the EU

Other Relevant Legislation

  • U.S. legislation and the FDA
  • Other major markets’ legislation
  • International Council for Harmonisation (ICH)
  • PIC/S
  • Medical devices and combination products

Nutzen & Mehrwert

Key Learning Objectives

On completion of this course, delegates will know and understand:

  • Why we have medicines laws and what they seek to achieve
  • UK mechanisms for controlling medicinal products
  • European mechanisms for controlling medicinal products
  • Similarities and differences in other countries’ relevant legislation, e.g. Brazil, Canada, China, India, Japan and the USA
  • International harmonization activities of ICH and PIC/S

Zielgruppe / Voraussetzungen

Who Should Attend

The Aspiring Qualified Person

Our training is generally considered as the best available and our QPs are held in high regard within the industry. Our training courses are accepted in the UK and by several EU countries including Ireland, the Netherlands, Austria, Hungary and Malta. You are more likely to become a QP with us than with any other training provider.

The Pharmaceutical Technical Professional

Not all people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control. Many industry professionals, from a range of disciplines, attend the courses as part of their continuing professional development. Taken with our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Kostenzusatz

Multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

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Kontaktinformation NSF, Health Sciences

NSF, Health Sciences

22-24 West End
YO62 6AF Kirbymoorside

 Telefonnummer anzeigen
www.nsfpharma.org

NSF, Health Sciences

NSF, Health Sciences

NSF provides education and training services to lead organisations in the healthcare industry. Courses in health science from NSF International have one goal – to bring change that drives improvements in workplaces. Globally known for high-quality content, NSF International is...


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