Tag Archives: Excipients

Get your Questions answered!

A 1-day non-residential course on
27 February 2014
at the Royal Society of Chemistry,
Burlington House, Piccadilly, London W1J 0BA, United Kingdom

 This Course gives you another opportunity to have your questions answered about the ‘Falsified Medicines Directive’ (FMD), which is one of the most significant pieces of pharmaceutical legislation to arrive for many years!

The urgent intention of the FMD is to protect European patients from receiving falsified medicines.

Outlined below are selected reasons why attendance at the Course might be important to position you as an up-to-date Regulatory or GMP Expert (or other person) in a role which requires your action, advice or other input into decisions being made for your company’s benefit.

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 intended 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 those who use, manage, supervise, regulate or give advice about these materials, to make intermediates or finished medicines, face new requirements.  That is likely to mean that there are new activities for you to know about and new actions to take.

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 will deliver up-to-date knowledge and understanding to delegates to help them and therefore their companies counteract the menace of falsified medicines.

Please use the links on our site to learn more about the Course.  There is information available on the main subject areas of the training, on the excellent panel of speakers and on the delegate package, which is priced to be attractive. You will find it easy to make your booking and you should not delay if you want to secure a place.

We look forward to meeting you and to sharing a lively programme with good sessions dealing with your questions.

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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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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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