Tag Archives: GMP

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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An excellent and varied panel of Speakers

In my previous post I emphasised how attendance at the Pharmaqmtraining.eu FMD course might enhance your performance as a ‘Regulatory or GMP’ Company Expert or other person such as a Freelance Consultant acting as an adviser to a pharmaceutical company or ancillary business.

In this post I want to provide you with information about the Team that will provide the training so that you can appreciate the extraordinary collective experience available to delegates and also see with whom you will have some networking opportunities on the day.

Chairman: Derek Calam is a Visiting Professor of Pharmaceutical Sciences, University of Strathclyde, a Member of the WHO Expert Panels for both Pharmaceuticals and Biologicals and Chairman of the WHO Committee responsible for allocating names to medical substances on a global basis.  He is a UK-nominated Expert at the European Medicines Evaluation Agency (EMEA) in London, and much more.

For over 25 years Derek has been advising the UK Regulatory Authority on quality matters concerning Chemistry, Pharmacy & Standards and Biological and Biotechnological Medicines.  He has also served as Chairman of the European Pharmacopoeia Commission, of the British Pharmacopoeia Commission and of the EDQM Steering Committee for Certification, Strasbourg.

SpeakersPaul Fleming is Technical Director of the British Generic Manufacturers Association (BGMA) which represents the views of the generic medicines industry in UK and has close and regular discussions with MHRA, other parts of the Department of Health and the NHS.  At a European level, Paul is a key Member of the Regulatory Committee of the European Generic Medicines Association, EGA. In both these roles, he is involved in the development and implementation of new regulatory guidance.

Paul has spent many years working for pharmaceutical generic companies in Europe at senior board level in roles covering drug regulation, pharmacovigilance and formulation development.  Previously, for six years he was a Pharmaceutical Assessor at the MHRA.

Geoff Mellor is Technical Director of the British Association of Pharmaceutical Wholesalers (BAPW) which represents full-line pharmaceutical wholesalers in the UK.  BAPW is a Member of the Brussels based European Association of Pharmaceutical Full-line Wholesalers, the GIRP.

Geoff leads for the BAPW on all technical, regulatory and liaison aspects and is the Association’s primary contact with the MHRA.  He is also a member of the GIRP Technical Committee, which covers aspects of health policy developments within the European Union.

Carl Mroz is the Director of Global Regulatory Affairs, EMEA for Colorcon Limited in the UK.  He is an active member of the International Pharmaceutical Excipients Council (IPEC) Europe, as the Chair of the Quality and Regulatory Affairs Committee and is also a Member of the European Pharmacopoeia Working Party on Functionality Related Characteristics, a Member of the British Pharmacopoeia Working Party on Excipients and the Panel of Experts on Inorganic Chemicals.

Carl is a past Chair of IPEC Europe and has been involved with the pharmaceutical industry for over 30 years in a variety of roles including Production, Quality Control, Regulatory Affairs and Quality Assurance.  He is an active international lecturer with particular expertise on compounded excipients used in conjunction with solid oral dosage forms.

Steve Porter is a highly experienced Quality Professional with over 35 years’ service in the Pharmaceutical Industry.  He is currently a Company Director at Steve Porter Pharma Consulting providing services in internal and supplier auditing, quality system design and enhancement, regulatory inspection preparations and remedial actions, design and delivery of training courses, supply chain design and evaluation, and QP services.  He is a Fellow of the Royal Society of Chemistry.

Steve has extensive auditing experience in the US, Europe and Asia (China, India, Japan). He has also served as a Board Member of IPEC Europe. He is an experienced International lecturer.

Until recently he was QA Director (Compliance), Global External Sourcing at Astra Zeneca. His many duties there included involvement with the company’s preparations for compliance with the Falsified Medicines Directive.

Mike Robertson designs our courses and he has created over 100 public conferences for other conference providers.  He is a Visiting Lecturer at King’s College, University of London and an experienced International lecturer.

Mike is an experienced freelance Pharmaceutical Regulatory and GMP Consultant at Pharmaceutical Quality Matters, a Quality Assessor on the WHO Prequalification Programme (Geneva – Copenhagen) and a scientific author on CMC and other subjects.

After more than 11 years in the pharmaceutical industry in QC & R&D operations Mike became eligible to register as a QP and then for 20 years, he worked at the Medicines Control Agency (MCA), now the MHRA in London, first as a Pre-Clinical (Nonclinical) Assessor and then as a Pharmaceutical Assessor.  He has also served on various bodies associated with the British Pharmacopoeia Commission, the EDQM and the European Pharmacopoeia Commission.

In total, a real wealth of expertise and experience!

Are you and your company up-to-date with the many developments arising from the FMD?

Look out for the next date for this Course and be sure to book your place quickly to avoid disappointment.  Places will be limited!

You can register your interest by clicking here.  Don’t be disappointed!

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Falsified Medicines (Quality Aspects): Tackling a major public health and safety problem

A 1-day non-residential course on
3 October 2013
at the Royal Society of Chemistry,
Burlington House, Piccadilly, London W1J 0BA, United Kingdom

The ‘Falsified Medicines Directive’ (FMD) 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 a 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 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 plan to 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 ensure 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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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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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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