A short course on Regulatory Affairs with emphasis on
Biopharmaceutical Drug Substances and Products, including Biosimilars

you can learn about:

• Biological products in lay and legal terms
• The legal basis of Innovator and Biosimilar applications for EU Marketing Authorisations
• The development and life cycle of a biotechnology-derived product
• Principles and scientific issues about the analytical Quality Control of biological macromolecules
• WHO involvement both in regulation and regarding reference materials
• Specification setting
• Stability issues
• Major potential biological contamination problems
• Regulatory and quality compliance
• The importance of excipients in many biopharmaceuticals
• Quality, nonclinical and clinical issues to be addressed in the Common Technical Document (CTD)
• Label expansion and new derivative development
• Multi-site manufacture and comparability
• The scientific challenge in developing Biosimilar (similar biotherapeutic) Products
• Recent changes from the European Medicines Agency (EMA) and the European Pharmacopoeia (Ph Eur) regarding control of risk of transmissible spongiform encephalopathies (TSE)
• The looming impact in 2012 of the new legislation on falsified medicines

You can find out more by visiting http://www.pharmaqmtraining.eu/brochures/biological_drug_substances.html

HURRY TO BOOK YOUR PLACE

It may interest you to know that using the booking form you can obtain a discount on booking two delegates at a time

Please wait for confirmation before finalising your travel plans

The delegates described the hotel with words ranging from good, through ‘very good’ to excellent, using additional words like ‘nice rooms (meeting and bedrooms)’, one of the best hotels and conference centres and ‘very friendly staff’.  The course content was variously considered substantial, good quality, particularly excellent, very useful and interactive and the ‘generics focus was a real asset’.  The lecturers’ delivery was ‘aimed at the whole audience’ and excellent.  The course dinner was considered a great addition to the two days.

It was very satisfying to me to have continuing confirmation that our training business model is appreciated by the users and beneficiaries.

Thousands of you know what works well in ‘shifting goods’.  My ‘goods’ are first-class pharmaceutical training courses and for me the issue is how best to draw them to the attention of the world, or at least that part of the world that has an interest in learning about how to achieve the lawful sale and supply of medicines in the European Union through the licensing process.

Here is what our courses / ‘goods’ comprise:

I shall welcome your constructive comments.

BANKING          INSURANCE          TELEVISION             PHARMACEUTICALS
to name just a few possibilities.

My work is associated with the pharmaceutical industry and regulatory affairs in particular.  Consequently, I am interested in particular aspects of pharmaceutical compliance.  I have written about some of these at http://www.pharmaqmtraining.eu/articles.html
I expect your views will be different to mine but nevertheless interesting to read.

12-13 October 2011

Legacy Falcon Hotel, Stratford-upon-Avon, United Kingdom

This will be a comprehensive course that blends EU pharmaceutical legislation, legal base and other official requirements and guidelines with appropriately-focused elements of pharmaceutical science, nonclinical and clinical investigations that are important to the development and licensing of generic medicines in Europe.

Building from first principles in several disciplines, delegates will learn about many important aspects of pharmaceutical development, manufacturing and control of the dosage forms, what comparator products are acceptable and the importance of comparative impurity profiles and of key pharmacokinetic parameters.

Submissions (MAAs) for generic medicines must have a substantial Common Technical Document (CTD) Module 3 and much attention in the course will be given to the Chemistry & Pharmacy components. However, some Module 4 and 5 issues will also be addressed, with emphasis on Qualification of impurities and on the importance of bioequivalence study report which has to be lodged in CTD Module 5.

The Course Leaders have years of experience as Assessors and Advisers to European Authorities and aim to guide you to a much better understanding of what is expected in Regulatory Applications for these important pharmaceutical products.

This course is suitable for people (likely to be from analytical, formulation, pharmaceutical development, manufacturing and regulatory/registration departments) needing to understand Abridged Applications for generic and other medicines. It will also be useful to people who want better to understand regulatory science and scientific writing and other skills needed for the creation of successful licensing dossiers.

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 and will give you great insight into the subject.

I hope to be able to welcome you to the two-days course at the 4-Star Legacy Falcon Hotel in October 2011. Check our conference package for its amazing value! Probably your only extras will be your travel costs!

Listed below are a few questions for you to consider.
1. GENERIC COMPANY APPLICANTS FOR MARKETING AUTHORISATIONS AVOID REPEATING PRE-CLINICAL AND CLINICAL STUDIES PERFORMED BY THE ORIGINATOR COMPANY.
DO YOU KNOW HOW THIS CAN BE DONE WHILST STILL ACHIEVING YOUR MARKETING OBJECTIVE?
2. HOW DO YOU OR WILL YOU CHECK THAT A VENDOR OF A DRUG SUBSTANCE IS A SUITABLE SOURCE OF SUPPLY?
3. WHAT IS BEING PROPOSED TO STOP INAPPROPRIATE PRODUCTS (DRUG SUBSTANCES, EXCIPIENTS AND DOSAGE FORMS) ENTERING THE SUPPLY CHAIN?
4. ARE YOU FAMILIAR WITH THE PEDIGREE OR TRACEABILITY CONCEPT? ARE YOU FAMILIAR WITH THE UPCOMING CHANGES INTENDED TO ADDRESS CONCERNS ABOUT FALSIFIED ACTIVE SUBSTANCES AND FALSIFIED MEDICINAL PRODUCTS?

These and many other subjects will be the subject of Expert and up-to-date presentations by Paul Fleming, the Technical Director of the British Generic Manufacturers Association (BGMA), and our other Expert Speakers.
BGMA represents and promotes the views of the generic medicines industry in UK and has close and regular discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) and various parts of the UK Department of Health and National Health Service. At a European level, he is a key Member of the Regulatory Committee of the European Generic Manufacturers Association, EGA. In both these roles, Paul is involved in the development and implementation of new regulatory guidance.

You can still book your place on the PharmaQMtraining.eu course “Regulatory Affairs with emphasis on UNDERSTANDING ‘SMALL MOLECULE’ GENERIC MEDICINES” running next on 12-13 October 2011, at Legacy Falcon Hotel, Stratford-upon-Avon, United Kingdom.
Please visit http://www.pharmaqmtraining.eu/course_schedule.html where you can access more information and a booking form. Paul and our other Expert Speakers look forward to meeting you and answering your questions.

Based on the maxim for biologicals that ‘process defines product’, it is vital to staff both in the pharmaceutical industry and in the licensing authorities to have an in-depth understanding of these special substances and of the complex methods and control systems used in their manufacturing processes.

There is enormous diversity in the nature of the starting materials for these processes, which is not surprising when you consider examples of product types such as recombinant proteins, hormones, growth and coagulation factors, monoclonal antibodies and vaccines.

Genetic engineering as well as cell- and tissue-culture technologies are often involved and raise further complex issues.

Manufacturing procedures may involve extraction and purification from microbial cells or human and animal tissues such as blood, or natural, hybridised or otherwise-modified tissue cells. The use of genetically-modified animals such as goats, rabbits and hens is a recent development.

Course delegates are likely to be from the pharmaceutical and biotechnology industries and working mainly in analytical, regulatory, Quality Assurance or management roles. Delegates at some of our courses have been Licensing Authority Assessors. The course is suitable for people new or relatively new to regulatory affairs as well as those who are more experienced, looking to update their knowledge about regulatory affairs and biologicals.

If you want to broaden your understanding of Regulatory Science for Biopharmaceuticals, our next course in early 2011 is right for you!

Register your interest here by ticking the Biologicals / Biotechnologicals box.

What is an innovator product?

What is a biosimilar product?

What makes a biological/biotechnological product different from non-biological ones?

At our course on “Biologicals” at the Legacy Falcon Hotel, Stratford-Upon-Avon, in early 2011, we will tell you in lay and regulatory terms.

As a delegate you will learn about the relevant Articles in EU legislation affecting pharmaceuticals and you will understand why and how biologicals and biological medicines are treated differently from non-biologicals.

There are many official guidelines to help you both to interpret the meaning of the law when developing a biological medicine and to compile acceptable IMP and MA dossier applications. We will help you in these tasks.

Much of the course will focus on relevant REGULATORY SCIENCE for Biopharmaceuticals. Previously our delegates have found the course incredibly useful! Register your interest here by ticking the Biologicals / Biotechnologicals box.

Biologicals

Biologics

Biotechnologicals

Biopharmaceuticals

Biological medicines

Biosimilars

Biogenerics

Similar biological medicinal product

Some of the above words or phrases have the same meanings and some do not! Do you use any other terms for these subjects?

People often use the expressions rather loosely as if they were interchangeable terms. Whilst there can be considerable overlap in such designations, there are differences which can be important in the pharmaceutical industry and to understanding regulatory matters in particular.

These and many other subjects related to the European registration of Biopharmaceuticals will be addressed in our upcoming course on “Biologicals” at the Legacy Falcon Hotel, Stratford-Upon-Avon, UK in early 2011. We hope to see you there!

Register your interest here by ticking the Biologicals / Biotechnologicals box.

[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.