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Oct
2017

Pharmaceutical Law & Administration - QP Module

United Kingdom, York

16 Oct 2017 - 20 Oct 2017

Entrance: £3,395.00 (excl.VAT)

Lunch: included
Multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
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Course Overview :

Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (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. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential. This is equally true for other pharmaceutical technical managers. This extremely popular QP training module is designed to ensure that, in an increasingly changing world, you have a deep and detailed understanding of… Why we have medicines laws and what they seek to achieve The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP The UK medicines legislative framework US and other international pharmaceutical legislation Other relevant laws and guidelines


About This Course :

Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QP). 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. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential. This is equally true for other pharmaceutical technical managers.

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


Key Learning Objectives :

A deep and detailed understanding of:

  • Why we have medicines laws and what they seek to achieve
  • The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP
  • The UK medicines legislative framework
  • US, ICH and other international pharmaceutical legislation and guidance
  • Other relevant laws and guidelines

This course is also RSC Approved.



Registration link :

  • NSF Online registration : Link

NSF contact :

Note : 

  • All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Course Outline :

European Medicines Legislation

  • The legislative framework in the EU
  • EU directives and regulations affecting medicines
  • Organization and function of EMA
  • Rules governing medicinal products in the EU (EudraLex)
  • Importation into the EU and distribution within the EU
  • Powers of the licensing authorities and adverse licensing reports
  • Pharmacovigilance
  • Role of the QP
  • EU marketing authorization, content, structure (CTD) and application routes
  • Variations to marketing authorizations
  • Non-clinical data/toxicology

Manufacturing and Wholesale Authorizations

  • Starting material controls
  • Parallel imports
  • Pack serialization and tracing
  • Managing contract services
  • Controlled drugs

UK Medicines Legislation

  • Background and development of UK medicines legislation
  • MHRA and VMD

Other Relevant Legislation

  • US legislation and FDA
  • International Council for Harmonisation (ICH)
  • PIC/S
  • Medical devices and combination products

We provide an optional post-course assessment

Subject Sessions :

  • Medicines Law – An Introduction
  • EU Law – An Overview
  • Global GMP Legislation
  • Legislation in the EU Affecting
  • Clinical Trials
  • The Role and Duties of the Qualified Person
  • The EU Marketing Authorization Application
  • Format, Content – CTD
  • Marketing Authorization – Routes and Variations
  • The Non-Clinical Dossier/Toxicology
  • Medicines Legislation: Authorizations for Manufacturing, Importing and Wholesale Dealing
  • Medical Devices Legislation
  • Route to Becoming a QP and Eligibility (UK and other Member States)
  • Adverse LicensingSession
  • European Legislation – Advanced Therapy Medicinal Products
  • Mutual Recognition Agreements of Inspection
  • Parallel Imports
  • Comparison of Human and Veterinary Legislation
  • Recalls – EU and US Laws
  • Regulatory Control of Starting Materials
  • UK Medicines Legislation
  • US Pharmaceutical Law
  • International Conference on Harmonization – Organization, Role and Recent GMP Activities
  • The Role of PIC/S (The Pharmaceutical Inspection Cooperation Scheme)
  • Borderline Products
  • Inspections and the Inspectorate
  • Pharmacovigilance
  • Controlled Drugs
  • Product Liability & Other Legislation to be Considered
  • Keeping Up-To-Date
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    Liz Allanson

    Consultant in Biotechnology

    NSF Health Sciences Pharma Biotech

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    Peter Gough

    Executive Director

    NSF Health Sciences Pharma Biotech

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    Rachel Susan Carmichael

    Executive Director

    NSF Health Sciences Pharma Biotech

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Resume

Liz Allanson is a pharmacist by profession and has a special interest in quality management and leadership skills. She spent almost 19 years as a GMP inspector with the UK MHRA, primarily as one of the senior managers in the MHRA Medicines Inspectorate. Her last position with MHRA was managing the GMP inspection team.

Ms. Allanson is eligible to act as a Qualified Person and is a registered IRCA lead auditor. Her areas of expertise include:

  • EU GMP pharmaceutical legislation and regulatory expectations, including requirements for investigational medicinal products
  • GMP and GDP compliance
  • Quality management systems
  • Clinical trial manufacture/packaging and QP release
  • Auditing and mock regulatory GMP inspections
  • Supply chain management

A chemist with a master’s degree in analytical chemistry, Peter Gough has nearly 40 years’ experience of pharmaceutical manufacture, control and quality management, culminating in the role of Senior Quality Consultant in Eli Lilly’s Global Quality Systems division. He has broad experience, particularly with quality control laboratories and the manufacture of solid dosage forms and active pharmaceutical ingredients. He was previously a partner at David Begg Associates (DBA).

Mr. Gough has extensive experience defining quality systems at a global level. He is eligible to act as a Qualified Person and is an Honorary Lecturer in GMP and Pharmaceutical Quality Management at the University of Strathclyde. He is a former member of the European Federation of Pharmaceutical Industry Association’s (EFPIA) Manufacturing and GMP ad hoc group and was EFPIA topic leader on the ICH Expert Working Group which prepared the Q9 Quality Risk Management Guideline. He was given the Leveraging Collaboration Award by the U.S. FDA for his contribution to the online ICH Q9 briefing pack. He has been a passionate advocate of the Quality by Design (QbD) approach to the development, registration and manufacture of pharmaceuticals.

Mr. Gough has been a strong proponent of the use of statistical data analysis techniques to drive continual improvement within pharmaceutical quality management systems.

Areas of recognized expertise include :

  • Pharmaceutical law
  • The role and duties of the Qualified Person
  • Pharmaceutical quality management systems
  • Pharmaceutical quality risk management
  • Good Control Laboratory Practice (GCLP)
  • Managing out of specification (OOS) and out of trend (OOT) results
  • The application of statistical process control tools
  • The manufacture and control of oral solid dose products

Mr. Gough is a Fellow of the Royal Society of Chemistry and of the UK Chartered Quality Institute (CQI) and former chairman of the Royal Society of Chemistry’s Qualified Person Assessor Panel and of the CQI’s Pharmaceutical Quality Group.

Rachel Susan Carmichael has over 20 years’ experience of pharmaceutical manufacture, control and quality management including nearly 11 years as a GMDP Inspector for the UK Competent Authority, the MHRA. This includes serving as the lead inspector representative within the MHRA for the transition from the Medicines Act to the Human Medicines Regulation, SI 2012 1916.

Ms. Carmichael is eligible to act as a Qualified Person under the provisions of EU Directives and is a member of the Royal Society of Biology. She has wide-ranging experience of inspecting against European Good Distribution Practice and Good Manufacturing Practice requirements in the UK, China, India and the U.S. to meet the associated quality standards for medicines (non-sterile and aseptic production, including radio pharmaceuticals) and the blood industry.

Her areas of recognized expertise include :

  • Manufacture and packaging of oral solid dosage forms
  • Good Distribution Practice
  • Good Manufacturing Practice
  • Blood industry: Blood establishments, hospital blood banks and plasma collection sites
  • Data integrity
  • Pharmaceutical law
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