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COMPLIANCE with the Falsified Medicines Directive
PROTECTING YOUR COMPANY'S / CLIENTS' INTERESTS

A one-day non-residential course
27 February 2014
Venue: Burlington House, Royal Society of Chemistry,
London W1


TIMETABLE

27 February 2014

Registration
09.15h
Course Begins
09.30h
Ends
17.00h


The Course topics include

(this is not necessarily the running order)

WELCOME AND INTRODUCTION
THE CHALLENGES AND HURDLES OF THE FMD
Framework of Official Requirements:
  • EU Pharmaceutical Legislation and Legal Provisions
  • For Active Pharmaceutical Ingredients (APIs) and Dosage Forms
  • For Investigational Medicinal Products (IMPs)
  • Official and Other Guidelines and Codes
  • Inspections, Equivalent Countries, Written Confirmations
RECENT FMD-RELEVANT ACTIVITY
  • European Commission (EC)
  • European Medicines Agency (EMA)
  • Heads of Agencies (HMA)
  • Trade and Other Associations
  • Contingency Plans
ACTIVE PHARMACEUTICAL INGREDIENTS (APIs)
  • API Sources and Associated GMP Risks
  • How will the FMD impact quality of outsourced APIs ?
  • Challenges, visibility and control of the global supply chain
  • Perspectives on Supplier selection
  • Documentary and Other Options for API Importation and Supply Chain Management
  • Expectations of the Inspectorates
  • Impact on Qualified Persons
EXCIPIENTS AND ATYPICAL SUBSTANCES
  • Excipients: What are these, what are their Sources?
  • Atypical Substances: What are these, what are their Sources?
  • How are they to be Regulated? Strictly or with Pragmatism?
  • Available Compliance Standards
  • Understanding Appropriate GMP
  • Formalised Risk Assessments
SECURING THE WHOLESALE DISTRIBUTION SUPPLY CHAIN
  • The British Association of Pharmaceutical Wholesalers (BAPW) and its Role
  • What does the FMD mean to the Wholesale Distribution Supply Chain?
  • BAPW Preferred Core Principles/Favoured Solutions
  • EU Guideline on Distribution

An Extra Feature!
MINI-WORKSHOP BASED AROUND PREPARED EXAMPLES AND DELEGATES’ QUESTIONS* ON COMMON FMD ISSUES

*Registered delegates can send advance questions for the Mini-Workshop to admin@pharmaqmtraining.eu prior to 7th February 2014. Alternatively, the Course Leaders will address questions you raise at the Course on 27 February 2014

CLOSE OF MEETING
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EXCEPTIONAL VALUE: £385.00 + 20% VAT
Your delegate package includes training from experts, training materials, certificate of attendance,
daytime food and drinks
BOOK HERE

MORE ABOUT THE BACKGROUND TO THIS COURSE

In recent years there has been increasing concern about damage to the world-wide supply chain for medicines, with consequent increased risk to public health and safety.

Many activities can affect pharmaceutical ingredients and associated materials during and after their complex manufacturing processes and physical journeys, via different types of intermediates, before as final drug products these goods eventually enter the EU marketplace. Supply chains can be incredibly complex.

Significant, indeed major, official responses to both the threat and the reality of falsified medicines has included the introduction and phased application of Directive 2011/62/EU, which amends Directive 2001/83/EC. The impacts on industry and on regulators are huge and certain necessary actions can occur outside the EU.

To prevent falsified medicinal products entering the legal supply chain and reaching patients new steps have been, are and will be required to ensure the integrity of quality systems for active substances, excipients and finished medicinal products. Manufacturers, exporters, importers, brokers, wholesale distributors, manufacturing authorisation holders, marketing authorisation holders and certain other parties in-between the categories and the patient have actions to take and responsibilities to meet.

This Course, delivered by our Experts, will explain to and update delegates about key parts of the legislation, official and other guidelines, codes and standards, actions to be taken, documentation to be obtained or created, and more, in order to clarify the impact that might be expected to fall on delegates in fulfilling their own particular duties.

The exact boundaries between current Good Manufacturing Practices (cGMP) and Regulatory Needs may be ‘grey’ and overlapping, so some knowledge of the bigger picture can be important even to a specialist. We must all strive to be compliant in the exercising of our particular roles in a global industry. In that way, we can each confer our strength to the supply chain which embraces numerous quality aspects from the designation of starting materials for the manufacture of drug substances through various stages leading eventually to the manufacture of the drug product and its delivery to the patient, with numerous and intermittent transportation activities being possible on a case-by-case basis.

Staff training is a vital part of GMP and regulatory compliance and we hope to be able to welcome you to our Course in order to deliver knowledge and understanding about how you can help protect your company and the public from the menace of falsified medicines.

WHO SHOULD ATTEND

The Course is expected to have a broad appeal. It should be of particular interest to many professionals in the pharmaceutical and chemical industries, and associated businesses:

  • Qualified Persons (QPs), QP trainees, Auditors, Engineers, Scientists, Technicians
    working in Production, Development, Control, Compliance and Regulatory / Registration
  • Pharmaceutical Assessors, GMP Inspectors, Scientific / Medical Writers
    working in Competent Authorities
  • Regulatory Consultants
  • Staff working in Import, Distribution and Sales Departments / Companies
with interests in
  • Preparation and Control of Active Substances
  • Selection, Risk Assessment and Control of Excipients
  • Qualification of Suppliers
  • Formulation and Pharmaceutical Development
  • Pharmaceutical Quality System
  • Regulatory / Registration Departments
  • Purchasing and Supply of Substances for Pharmaceutical Use, Intermediates and Finished Medicinal Products

COURSE LEADERS

The trainers will be Professor Derek Calam, Paul Fleming, Carl Mroz, Geoff Mellor, Steve Porter and Dr Mike Robertson (more about Speakers here)


BOOKINGS
Book Here


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