Contact us

Pharmaceutical Law and Administration Training

Dates

Times

5 days18.5 hrs VILT, 12.5 hrs self-paced

Location

Virtual Learning

Availability

Dates

Times

5 days

Location

In-Person - York, United Kingdom

Availability

About This Course

Pharmaceutical law and administration are key foundation knowledge requirements for all QPs. This course provides comprehensive coverage of the medicinal product legislation in both the EU and UK. The course meets the requirements of the UK QP Study Guide and also provides comprehensive coverage of EU legislation for EU QPs.

Our highly interactive training course provides aspiring QPs, and other pharmaceutical quality professionals, the EU and UK pharmaceutical legislation understanding needed to carry out their duties with skill and authority and to ensure compliance with relevant laws.

Subjects Covered

  • Pharmaceutical legislation in the UK, Europe and the US
  • 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 regulatory agencies
  • The key role that QPs and pharmaceutical quality professionals must play to ensure compliance with international legislation in the interest of patient safety

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


If you choose our virtual learning option, we will deliver training via a combination of live instructor-led virtual classrooms and self-paced online learning. We will send you full details following registration.

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
  • An overview of US legislation for controlling drug products
  • International harmonization activities of ICH and PIC/S

Course Outline

European and United Kingdom Medicines Legislation

  • The legislative frameworks in the EU and UK
  • EU directives and regulations affecting medicines
  • UK Medicines and Medical Devices Act and regulations affecting medicines
  • Laws governing clinical trials and investigational medicinal products
  • Organization and function of the EMA and MHRA
  • EU GMP (EudraLex Volume 4) and PIC/S GMP
  • EU and UK marketing authorisation, content, structure (CTD) and application routes
  • Variations to marketing authorizations
  • Non-clinical data/toxicology
  • Importation and distribution into the EU and UK
  • Powers of the licensing authorities and sanctions
  • Pharmacovigilance
  • Differences for veterinary medicines

Manufacturing and Wholesale Authorizations

  • Starting material controls
  • Mutual recognition of inspection agreements (MRAs)
  • Parallel imports
  • Controlled drugs

UK Medicines Legislation

  • Background and development of UK medicines legislation
  • The UK Medicines and Medical Devices Act and Statutory Instruments
  • The roles of the MHRA and VMD

Other Relevant Legislation

  • US legislation and the FDA
  • International Council for Harmonisation (ICH)
  • Pharmaceutical Inspection Cooperation Scheme (PIC/S)
  • Medical devices and combination products

Who Should Attend

The Aspiring Qualified Person

Our training is generally considered as the best available and our QPs are held in high regard in 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 Quality or 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.

Course Tutors

The course features guest speakers, including one from the UK MHRA, and tutors are selected from the following:

Rachel Carmichael - Rachel is a former UK MHRA GMP Inspector. She has extensive knowledge of pharmaceutical law and its practical implementation.

Peter Gough - Peter has over 45 years’ experience in the pharmaceutical industry and specializes in EU and U.S. pharmaceutical law. He has had direct involvement in discussions with regulators on quality and GMP, having been the EU industry leader on the ICH Q9 working group.

David Waddington - With over 30 years’ experience in various quality roles for three major international pharmaceutical organizations, David has extensive knowledge on the practical and pragmatic application of pharmaceutical law in manufacturing and packaging operations.

Helen Erwood - Helen is an expert in regulatory affairs. She started her career in 1985, became a global director in 1993 and has run her own consultancy since 1996.

Discounts

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

Qualified Person Training With NSF International

Watch the video
  • Excellent course, very good and detailed grounding in all aspects of law and administration for medicinal purposes.
    Suzanne Moore
    RB, UK
  • Thought the pace of the tutors providing the lectures was excellent and their knowledge and openness has made the learning element effective.
    Alison Jordan
    DDD, UK
  • Really enjoyed the teamwork-based activities. Tutors are extremely knowledgeable, convey content very well.
    Christie Hayes
    LanesHealth, UK

Additional Recommended Courses

CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many ​experienced ​auditors ​decades ​to ​develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. ​During ​the ​course, ​learners ​will ​plan, perform, ​and ​report ​audits ​based ​on ​case ​studies ​that ​simulate ​internal, ​supplier, ​and ​third-party ​audits ​utilizing ​MDSAP ​audit criteria. ​Learners ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning and performing audit activities, ​evaluating ​audit ​evidence, and documenting audit findings.

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).

Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

By the end of this course you should be able to:

· Describe the purpose of:

  • Quality management systems
  • Quality management system standards
  • Management system audits
  • Third-party certification

· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018

· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.

Price: $2800.00

MDSAP Internal Auditor Training

This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.

This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.

An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.

This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
  • Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
  • Recognize the competency and training requirements for AO auditors
  • Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
  • Calculate audit time and plan an MDSAP Lite internal audit
  • Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
  • Identify post-audit MDSAP activities including NC grading
  • Recognize the outcomes and goals of an MDSAP audit

Price: $1200.00

EU IVDR Internal Auditor

This virtual instructor-led two-day course provides guidance on how to prepare for, plan, and conduct an internal or supplier audit based on the EU IVDR. This course also focuses on ISO 13485:2016 relative to its correspondence with the EU IVDR.

This course provides practical instruction for auditors and managers performing, facilitating, or managing internal and supplier audits against criteria contained within the European Union In Vitro Diagnostic Regulation (EU IVDR).  The instructor will review the regulation in depth from the auditor’s perspective and provide practical instruction for preparing for, planning and conducting EU IVDR audits according to NSF’s formal, documented EU IVDR Audit Model.

This course includes a two-hour eLearning prerequisite module, EU IVDR – A Comprehensive Overview, to be completed prior to the start of the live instruction. The self-paced eLearning covers every aspect of the regulation and identifies key pre- and post-market requirements associated with EU IVDR – standard regulatory requirements that must be met by all In Vitro Diagnostic manufacturers wishing to do business in the EU regardless of IVD classification.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify Key Articles and Annexes of the EU IVDR
  • Recognize Intent of Requirements as Described in Recitals
  • Identify Classification Implementing and Classification Rules
  • Identify General Safety and Performance Requirements (GSPRs)
  • Recognize Content of Technical Documentation
  • Identify Post-Market Surveillance Reporting and Vigilance Obligations
  • Recognize one EU IVDR Audit Model
  • Plan an EU IVDR Audit
  • Document Nonconformities against EU IVDR requirements

Who should attend:

This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.

Price: $1200.00