Regulatory Affairs – esp. Biopharmaceuticals

Organisation:: EUCRAF Ltd.
Ort, Bundesland, Land:: Freiburg, Baden-Württemberg, Germany
Typ:: Part-time
Certificate:: M.B.R.A.
Duration:

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Programme

The subject area Regulatory Affairs ensures that the proof of the quality, safety and efficacy of the medicinal product is demonstrated to be in line with legal requirements for the purposes of marketing safe and efficacious medicinal products solely in the interests of public health.

The unique seminar programme "Regulatory Affairs for Biopharmaceuticals including ATMPs" provides with ten seminars key education in the biopharmaceutical-related regulatory affairs. This seminar programme also allowing to receive a specialised degree based on the attendance of the whole course is available for the first time in Europe. It meets the requirements of the pharmaceutical industry and of the agencies regulating medicinal products, in particular biopharmaceuticals and advanced therapy medicinal products (ATMPs). It focuses on biopharmaceutical-related regulatory affairs relevant for European procedures but also offers knowledge on regulations and procedures valid outside the EU.

The programme is for individuals who are about to start a career in regulatory affairs or who want to continue their training in this special field. The principles of drug development and regulatory affairs applicable to biopharmaceuticals are basically the same as those for common medicinal products. However, various specific requirements are adapted to biopharmaceuticals due to their particular nature. The understanding of these distinct requirements is essential for successful development and authorisation of biopharmaceuticals. The seminar programme provides this know-how and thus meets current needs of companies developing new biopharmaceuticals and agencies in charge of their authorisation. Both are in need to recruit specifically trained staff due to the increasing role of biopharmaceutical medicinal products.

OUR OFFER

Postgraduate MSc

Programme of 10 Seminars of 3 - 5 days each (Freiburg, Strasbourg and Langen), total 40 days
60 ECTS, degree from our partner, the University of Strasbourg
Pre-reading, homework, case studies, interactive lectures, presentation skills, use of modern communication technique
Each seminar is followed by an exam
Master thesis
Start: anytime

Certificate Programme

Programme of 10 Seminars of 2 - 4 days each (Freiburg, Strasbourg and Langen), total 31 days
Pre-reading, case studies, interactive lectures, presentation skills, use of modern communication technique
Start: anytime

Seminars

10 Seminars of 2 - 4 days each (Freiburg, Strasbourg and Langen)
Can be booked individually
Case studies, interactive lectures, use of modern communication technique

Seminar Sharing

Company arrangements are offered!
Enjoy the possibility of sending different employees to different seminars
Contact us fo special offers

The course/seminar language is English.

The full programme runs every year. Course cyle beginns with Seminar 1 starting in each September. Full flexibility is offered - jump in at any point and put together your own schedule over 1-2 or 3 years!

SPECIAL EVENTS

Annual meeting - "What currently matters for biopharmaceuticals"
Speacial topics!
Interactive coaching concept

Focus

The programme focuses on the EU but covers the essential details for the systems in US, Japan, Switzerland and other regions such as China.

First-hand expertise is provided by the distinguished speakers of the programme from:

Health authorities
Universities of Freiburg and Strasbourg
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Global and EU pharmaceutical and biotechnology companies

Innovative training concept

First-hand experience lectured with focus on practise and cases
Group work on practically relevant cases
Interactive discussion
Development of relevant skills by team work and role play

Gabriele Dallmann
Study Director

Target audience

The objective of the practice-oriented, Postgraduate Master Course is to acquire or further develop the expertise and experience required for a Regulatory Affairs professional with focus on biopharmaceuticals.

By participating in the course, while using new media and collaborating in practice-orientated case studies, the attendees will gain expertise and skills enabling themselves to fulfill the role of a Regulatory Affairs’ professional.

Emphases/Curriculum

The lectures are given in 10 thematic seminars. Seminars, group work and case studies are scheduled in ten organizational blocks for those students who attend the whole course.
Seminar 1 "European pharmaceutical regulatory environment":
(Freiburg i. Br., Germany)

Seminar 2 "Regulatory Procedures in the EU, USA, Japan and other regions" (Freiburg i. Br., Germany)

Seminar 3 "Registration of blood products, vaccines and ATMPs" (Freiburg i. Br., Germany)

Seminar 4, Part I "Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier" (Paul-Ehrlich-Institut, Langen, Germany)

Seminar 4, Part II "Non-clinical and clinical development of biopharmaceuticals including biosimilars and the Module 4 and 5 requirements" (Strasbourg, France)

Seminar 5 "Specific considerations for the development and authorisation of biopharmaceuticals for children" (Freiburg i. Br., Germany)

Seminar 6 "Pharmacovigilance - Post-authorisation surveillance standards to meet regulatory requirements for product safety" (Freiburg i. Br, Germany)

Seminar 7 "The roles of the supervising authorities and the essential characteristics of quality systems" (Strasbourg, France)

Seminar 8 "Scientific advice, regulatory strategy and health technology assessment" (Freiburg i. Br., Germany)

Seminar 9 "Good Regulatory Affairs practice: communication skills, project management and tools for the daily practice": (Freiburg i. Br.)

Practical relevance

The selection of course leaders and speakers is very well balanced and solely driven by the intention to provide a course of high quality and practical relevance. Specific didactics help the attendees of the course to learn the scientific armamentarium, but also to develop the practically relevant techniques and soft skills important for a successfully acting Regulatory Affairs' professional. This includes interaction with experts from agencies and companies who give the lectures and case study exercises simulating important aspects of daily work of a regulatory affairs professional.

Admission/Entrance requirements
Part-time:
Number of participants max.:	30
Number of applicants:	n.a.

1. Fees applicable for individual seminars from September 2012 (starting with Seminar 1) and for the Course of 2012/2013 are listed below. Fees below do not include VAT (19%) Fee for 4-day seminars (1, 2, 4.1, 4.2): 2.800 EUR for companies, 1.720 EUR for academics/government Fee for 3-day seminars (3, 7, 8): 2.100 EUR for companies, 1.320 EUR for academics/government Fee for 2- day seminars (5,6, 9): 1.400 EUR for companies, 920 EUR for academics/government Postgraduate Master Course: 16.300 EUR for companies, 10.200 EUR for academics/government, 7.000 EUR for private persons Certificate Programme: 13.000 EUR for companies, 8.100 EUR for academics/government, 5.580 EUR for private persons 2. Fees for single seminars upto Seminar 9 (of Course 2011/2012) in 2012 are available on the website. 3. German VAT (19%) will be added to the fee on the invoice The booking fee of individual seminars include participation on the lecture, seminar materials, lunch, refreshments, snacks at coffee breaks, participation on social event, certificate of attendance, but exclude accommodation. The booking fee of the Postgraduate Master Course includes participation on the lectures and activities of all nine seminars, all lecturing materials, examination registration and participation fees, lunch, refreshments, snacks at coffee breaks, participation on social event, but exclude accommodation. The booking fee of the Certificate Programme includes participation on the lectures and activities of all nine seminars, all lecturing materials, lunch, refreshments, snacks at coffee breaks, participation on social event, certificate of attendance, but exclude accommodation. Entry requirements: Candidates for the Postgraduate Master Course "Regulatory Affairs esp. Biopharmaceuticals" must hold a degree from a recognised institution in either pharmacy or medicine or another relevant life science or health subject. Candidates whose first language is not English must also prove knowledge of written and spoken English sufficient to enable them to undertake the course. Exceptions may be made on an individual case basis. Application:** A new course cycle starts in each September. A full course can be started any time with any seminar and full flexibility is offered. The course can be finished within one year or can be extended over 2-3 years. Please send applications 6 weeks prior to the seminar you wish to start with.

Languages
Language(s) of instruction:	English
Going abroad:	possible

Information material

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Organisation

EUCRAF is an initiative of Dr. Gabriele Dallmann, an internationally recognized expert in biopharmaceutical regulatory affairs and ex-regulator of the German Regulatory Agency Paul-Ehrlich-Institut, Prof. Dr. Andreas Bechthold, Pharmaceutical Faculty of University Freiburg, Director of Department Pharmaceutical Biology and Biotechnology and Dr. Gertrud Thormann-Huber, who has unique and long-standing industry expertise in Regulatory Affairs of biopharmaceuticals.

Pharmaceutical industry and agencies continuously need to recruit new staff in Regulatory Affairs and increasingly search for professionals with the distinctive knowledge required to handle biopharmaceuticals adequately.

EUCRAF provides the opportunity of a specialized education in the area of biopharmaceutical-related regulatory affairs.

EUCRAF is independent, does not endorse, recommend or privilege particular companies or establishments, products, services, or technologies.

Study in Freiburg

The course will mainly take place in Freiburg, a town in the so-called Tuscany of Germany, located in the Southwest of Germany. Seminars 4.2 and 7 will take place in Strasbourg. These two cities are located in the three-country-corner France, Germany and Switzerland. Here you find accumulated pharmaceutical industry, research institutions and scientific excellence by the universities Freiburg, Basel and Strasbourg making this area a highly attractive region for life science industry and institutions. Seminar 4.1 will take place in Langen near to Frankfurt at the Paul-Ehrlich-Institut.

Other locations might be arranged. The venue of each seminar will be announced on the website www.eucraf.eu in due course prior to start of the individual seminar.