Tag Archives: pharmaceutical regulatory training

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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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 Unique Pharmaceutical Regulatory Training Resource

Announcing the latest online streaming video training modules for individual self-development programmes

A NEW WAY TO RECEIVE OUR TRAINING, STARTING NOW AND AT TIMES CONVENIENT TO YOU

The current collection of our e-Training Modules in the “HOW MEDICINAL PRODUCTS ARE LICENSED IN EUROPE” series is:

  • Training Module 1: Overview of the EU Regulatory System: Institutions, Agencies and other Involved Bodies
  • Training Module 2: Regulatory Overview of the Role of the European Pharmacopoeia
  • Training Module 3: On Pharmaceutical Licensing, its Legislation and Useful Guidelines
  • Training Module 4: An Introduction to the Legal Basis for a Marketing Authorisation
  • Training Module 5: Why …. and How to …. provide Drug Substance Data in support of a Marketing Authorisation Application

The selection list will grow and new additions are already in preparation.

More than 800 million Europeans live in about 50 countries in Europe. They have or strive for access to modern medicines.

For about 50 years there has been an evolution of pharmaceutical regulatory systems and industry practices aimed to deliver safe and effective drug products to prevent or treat ill-health.

The numerous national and multi-national official institutions and legal and procedural elements involved in this regulatory system are complicated to understand. The video training modules explain the complex frameworks within which global innovator and generic companies have to operate in the European Union and much more.

The European Pharmacopoeia has an inescapable influence on the Quality of human and animal medicines sold or supplied in the European Union (EU) and beyond. Much of its content is, in appropriate situations, mandatory and not just for guidance. Our e-Training helps people working in research, development, manufacturing, analytical, regulatory and other roles in the chemical, pharmaceutical and biopharmaceutical industries to know which pharmacopoeial requirements MUST be met and when!

The legal basis on which a Marketing Authorisation application may be submitted to and hopefully approved by the Licensing Authorities is another complicated area that is navigated with examples in the video training modules. It is important because it determines the nature and extent of the supporting information on pharmaceutical, non-clinical and clinical subjects that must be compiled in Common Technical Document or CTD.

The e-Training series offers regulatory insight drawn from the expertise of former EU regulators with enormous experience in different branches of the pharmaceutical industry and deals with legislation, official and other guidelines, procedures, policies and practices of relevance to gaining and maintaining Clinical Trial and Marketing Authorisation approvals. The training is delivered with care, clarity and expertise and each online module ends with an on-screen written reprise to help reinforce the learning process.

Choose a presentation that interests you. Pay only a fraction of the cost of attending a Course in person. Pay by credit card or PayPal. For a single payment watch a presentation on several occasions within a defined period, stopping and re-starting it as you wish.

This should be an easier way of learning and we certainly try to make it so!

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WHO DECIDES ON TRAINING?

I believe that individuals have a personal responsibility to manage their careers as best they can, to further their professional and personal development.  Do you agree?

Individuals can ask their employers to arrange for appropriate training to be delivered.  Do you think that this takes courage, at least for some people?

Amongst your circle of contacts, do you think individuals are likely to be proactive enough to seek out training courses for themselves?  I guess some will have the ‘nerve’ or dare I say it the ‘good sense’ to do so but others will ‘play safe’ or just be too timid to take the risk.  But as I stated earlier, individuals do have the responsibility, indeed must take some responsibility for their career development.

Do you want to share your views about ‘managing your career development’ on this post?
If training requests are met, the individuals gain new skills, expertise and competences subject to having chosen appropriate courses in the first place!  The employers stand to benefit through improved work performance, productivity increases and staff motivation.

If requests are denied without good reason, the individual might be wise to contemplate career development in another company!  Ponder the question: “Is my employer keen to have well-trained and motivated staff?

In a few small surveys I have carried out about delegates to PharmaQMtraining.eu courses, there has been a majority of respondents stating, that their attention was drawn to the courses by their managers.  Does that pro-active help from managers surprise you?  I have to admit that the outcome came as a surprise to me but was one that delighted me.

Let’s contemplate further the employers’ responsibility to help develop their employees’ knowledge and expertise.  There is mutual benefit to be gained, not least in important areas of regulatory compliance that concern us all.  Providing training opportunities and encouraging excellence helps to secure the objective of having a well-skilled and knowledgeable workforce.  Employers are ideally placed to take the lead, acting through their managers, designated mentors or other guiding staff, to ensure that appropriate training is delivered to their employees.  This is all rather obvious when one stops to think about it!

Of course, in the current difficult economic circumstances I have heard that some businesses have cut their training budgets to reduce expenditure.  This is a well-known reaction to recessionary forces.  Have you had personal experience of such cut-backs and do you know if there is a time limit on them?

For successful businesses like most in the pharmaceutical industry, the knee-jerk reaction to cutting back on training seems to be very unwise in the longer term.  Pharmaceutical industry staff are generally well paid and involved in projects with long lead times.  It would seem curious to neglect staff training and thereby risk greater inefficiency as staff competences, compliance and commitment would tend to decline.  A company cannot afford for too long, if at all, to ‘put on hold’ the career development of expensive and scarce staff.

If you have any supervisory role, you may have subordinate colleagues for whom you can recommend and secure relevant training opportunities.  Are you helping to lead, inspire and drive your company forward towards prosperity by boosting the effectiveness of your staff?

Is Pharmaqmtraining.eu able to help you?
Pharmaqmtraining.eu provide pharmaceutical regulatory training in various forms:
in-company training, public courses, e-training.  Appropriate choices can result in suitable training for beginners, for intermediate or for experienced staff.

Our repertoire is somewhat specialised towards both the ‘Quality’ area and ‘administrative/legal’ subjects like the legal base for Marketing Authorisations (MAs), types of MA submission procedures and licensing documentation.  However, it is worth remembering that most projects and most MAs have to be underpinned by pharmaceutical (chemistry and pharmacy) work and of course by proper documentation; Pharmaqmtraining.eu have the up-to-date regulatory insight and expertise on these and other subjects that your company could find useful.

We use various experts mostly drawn from the Pharmaqmtraining.eu panel of trainers with high levels of experience and attainment in various professional fields.

If you have any questions about what we can deliver, please contact me at mike@pharmaqmtraining.eu.

If you have any answers to my questions, please let me have them either via this blog post or by email.  Thank you.

Dr Mike Robertson

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CTD Module 3 Training Course – The Pharmaceutical Dossier

30 September – 1 October 2010, The Legacy Falcon Hotel, Stratford-upon-Avon, UK

[Currently there are only 4 delegate places remaining so please email admin@pharmaqmtraining.eu to check availability before booking online]

In our CTD Module 3 course you will learn about the 4 current ways in which a Marketing Authorisation (MA) applicant can provide information to the authorities about the synthesis (GMP or otherwise), control and (sometimes) the stability of the Drug Substance.  Delegates will also learn about which methods do not apply in certain specific cases.  Not only are there requirements but sometimes there are additional options.

You will also learn about the many, key regulatory issues that impact on the Drug Product.

Many applicants are prone to ‘getting things wrong’ and attention will be given to common deficiencies encountered in regulatory assessments of the Drug Substance and Drug Product.

Many applicants are prone to ‘getting things wrong’ and attention will be given to common deficiencies encountered in regulatory assessments of the Drug Substance.  However, some applicants get things right first time which proves that this is achievable and hopefully that is the objective to which all companies aspire.

If you want to improve your understanding of these complex issues, why not take a more detailed look at the course agenda.  It is only a small document to read now but be assured that the course is comprehensive, well rehearsed over many public appearances and has always been well received by our many previous delegates.

I hope to be able to welcome you to the two-days course at the 4-Star Legacy Falcon Hotel later this month.  Check our conference package for its amazing value!  Probably your only extras will be your travel costs!

If you want more information about PharmaQMTraining.eu, please have a look at the Introductory video here.

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