WHO SHOULD ATTEND FOR TRAINING ON THE FALSIFIED MEDICINES DIRECTIVE?

A new Course being held on 3 October 2013 in London on the FMD is expected to have a broad appeal because of its topicality and because so many parties involved with the pharmaceutical industry will be affected by the legislation.  If you are reading this, my guess is that your work role will be enhanced if you know about the new developments.

The Course should be of particular interest to many professionals, in the pharmaceutical and chemical industries and associated businesses, such as:

  • 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
  • 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

The title of the Course is

FALSIFIED MEDICINES (QUALITY ASPECTS)

Tackling a major public health and safety problem

Click here to see the course outline, speakers, venue, timings and more.

Book quickly as places are limited.

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Did you know that Germany ……

…. is the only country in the EU using border controls to apply the new API importation rules?

You will find out much more about the importation into the EU of active substances from third countries if you attend our Course on Falsified Medicines (Quality Aspects) which is referred to in more detail in the blogpost of July 20, 2013.

Book quickly to ensure your place on this highly-topical Course about a series of new developments with wide-ranging impacts.

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Possibly one of the announcements you’ve been eagerly awaiting this week!

We are pleased to announce our new Course addressing the implementation of

the ‘Falsified Medicines Directive’ (Directive 2011/62/EU)

A one-day non-residential course
FALSIFIED MEDICINES (QUALITY ASPECTS)
Tackling a major public health and safety problem

Thursday 3rd October 2013
Venue: Burlington House, Royal Society of Chemistry, London W1

The ‘Falsified Medicines Directive’ is one of the most significant pieces of pharmaceutical legislation to arrive for many years! The urgent intention is to protect European patients from receiving falsified medicines.

If you are involved with the production of active substances you will need to take serious account of this new legislation and the various means by which its Articles have been, are being and will continue to be applied in the daily life of the global pharmaceutical industry.

In addition and not surprisingly there are many legal changes taking effect that impact on excipients, also to protect the public from falsified medicines.

Most EU companies, aiming to ensure compliance with the new law, face the prospect of carrying out a lot more international and European work. However, it is not just European companies that are affected. This EU legislation has major impacts on a substantial number of parties operating outside the ‘European Community’.

Companies and people involved in the distribution or other movement of pharmaceutical materials from one place to another or with the use of these materials to make intermediates or finished medicines face new requirements, which means activities to know about and actions to be taken.

Unless you are already sure that you understand fully the changes being required, you would be wise to book your place on our new Course. We plan to deliver up-to-date knowledge and understanding to delegates to help them and therefore their companies counteract the menace of falsified medicines.

Follow the links on our site to learn more about the Course and to make your booking. We look forward to meeting you and to sharing a lively programme with good sessions dealing with your questions.

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
  • 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
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Some impacts of the Falsified Medicines Directive 2011/62/EU (amending Directive 2001/83/EC)

Falsified active substances and active substances that do not comply with applicable requirements of Directive 2001/83/EC pose serious risks to public health. 

In recent blog posts I have pointed out certain new developments arising because of the Falsified Medicines Directive (FMD) that affect the control of API’s.  Today I want to write about excipients!

Excipients and there are more than a thousand used in EU medicines are also subject to the new FMD legislation.  For instance the Directive states:

“There is a range of different good manufacturing practices that are suitable for being applied to the manufacturing of excipients.  In order to provide for a high level of protection of public health, the manufacturer of the medicinal product should assess the suitability of excipients on the basis of appropriate good manufacturing practices for excipients.”

This requirement will be achieved by formalised risk assessments to judge if each excipient is suitable for its intended purpose [refer to Articles 46(f) and 47 (fifth paragraph) of the FMD].

To increase your understanding of the regulatory and compliance issues affecting Substances for Pharmaceutical Use please book to reserve your place at our upcoming (2-3 July 2013) CTD Module 3 course in London.  Bookings close very soon!

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Be prepared for your changes!

The European Commission published updated procedural and classification guidance regarding variations on 16 May 2013.

Details are provided of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures.

The Guidelines replace existing guidelines with an effective date of 4 August 2013 and apply to variations to centralised and national marketing authorisations.

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Have you seen what is coming?

Recent developments influencing the updating of our popular CTD Module 3 course include new legislation (the Falsified Medicines Directive), new guidance on impurities particularly in drug substances, the upcoming 8th Edition of the European Pharmacopoeia …. and more. 

At our course we anticipate keen interest in our ‘FMD explanations, consequences and updates’, and an informative, group interactive discussion on these subjects.  FMD impacts are many and apply from ‘where and how the drug substance is synthesised’ through numerous aspects of ‘dosage form manufacture, any import into the EU, and other facets of distribution, traceability and verification’ to ensure that the patient receives the intended pharmaceutical treatment.

In addition, other specific FMD questions to be addressed include:

Which Member States remain slow to transpose the FMD into national legislation?

Which countries are Equivalent Countries?

Which countries will issue Written Confirmations?  Will some countries have a number of State systems rather than a single national one?

Are contingency plans in place for certain ‘at risk’ situations in certain Member States?

More personally, are you someone who has already seen the ‘FMD train coming down the track’ probably from distant places, and wants to learn much more?  Or is this fresh news to you?

The evolving compliance issues are hugely important extending as they do from ‘active substance starting materials and the definition and acceptance thereof’ right up to the point of ‘dispensing of medicines in local pharmacies in our own communities’ …. and lots that goes between!

Rather a lot of new Quality subjects for pharmaceutical regulatory personnel and others to learn about, on top of the basics of Module 3 regulatory science!

Please hurry to book if you want to secure a place.

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Designating API starting materials acceptably in a chemical synthesis

Making the correct designations of ‘active substance starting materials’ in a chemical synthesis can be very difficult but is extremely important to your company.  There is a subjective element to overcome and only a limited set of rules to help you with the decisions.  These will be discussed and some examples considered in our comprehensive CTD Module 3 course in London on 2 – 3 July 2013.

The impact of the designations on GMP compliance with regard to development costs and to the time taken to gain regulatory approvals of Marketing Authorisation applications can be huge, so increasing your understanding of the many issues is more than sensible!  Please hurry to book if you want to secure a place.  Bookings close soon.

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Latest version (Revision 10) of the Module 1.2 Application Form for European Centralised or National Marketing Authorisation (MA) Applications

(including those using Mutual Recognition or Decentralised Procedures) has now been published  within Eudralex Volume 2B in pdf and Word formats by the European Commission’s Health and Consumers Directorate-General and is available for use.

As from 1 July 2013 when the Republic of Croatia joins the European Union the form can also be used for MA applications to include this new Member State which has the code HR.

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A reminder that bookings are now open for our next PHARMACEUTICAL REGULATORY TRAINING COURSE

Title:  On the Background, Content and Detail of Module 3 of the Common Technical Document (CTD), the ‘QUALITY MODULE’ being held on 2-3 July 2013 at the Royal Society of Chemistry, Burlington House, Piccadilly, London

Do not delay too long to book your place as numbers are limited!

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