This is an English version of my page.
Apologize, but it is only an excerpt of the informations of the German
version because at lot of these informations are of national interest
only. Back to the German version here:
This is the Page of "Regulatory
Science and Sevices"
Univ.-Prof. Dr. rer. nat. habil. Harald G. Schweim
Chair "Drug Regulatory Affairs"
0172-4503-544 (mobil); Fax:
Curriculum vitae Harald
Click on the text: What’s
a Regulatory Affairs Manager?
We are searching cooperation with
Pharmaceutical Industry, pharma-associations, etc. and we are glad about
inquiries. As services we offer cooperation in scientific questions
( e.g. Guidelines, Regulations), projects, on the basis of support for
Ph.D. thesis or expert-reports. Also consultancy and aid on all regulatory
projects and problems or regulatory support on drug developement is our
buisiness. But also individual case-by-case consultation is possible.
Dear Professor Schweim, We are pleased to inform you that the final version
of your article with full bibliographic details is now available online:
Article title: Synergistic effects – is it possible to make ‘the devil an
angel’? Reflections of a senior regulator Article reference: SYNRES24
Journal title: Synergy, Final version published online: 07-Jan-2017, DOI
information: 10.1016/j.synres.2016.12.002 To help you access and share your
article, we are providing you with the following personal article link,
which will provide free access to your article, and is valid for 50 days,
until February 26, 2017
https://authors.elsevier.com/a/1ULQ77tLmv~AC5 You are also welcome to
email the link to your colleagues, or post the link on your own homepage,
to tell your network about your new publication. Anyone who clicks on the
link until February 26, 2017, will be taken to the final version of your
article on ScienceDirect for free. No sign up or registration is needed -
just click and read!
Training for the Chinese
national comp. Authority (SFDA) 2013
From the 30.11.09 until the 06.19.09 we had a training-course for
the SFDA, China. The following article in the German DAZ in
Our main event in 20015. We hosted a second time
INTERNATIONAL CONGRESS "PHYTOPHARM 2015", 22 - 24 July 2015, Pharm.
Inst. Bonn, Germany Scienific Program,
Presentations and Abstracs even Photoimpressions
Our main event in 2009. We hosted
INTERNATIONAL CONGRESS "PHYTOPHARM 2009", 29 - 31 July 2009, Pharm.
Inst. Bonn, Germany Scienific Program,
Presentations and Abstracs even Photoimpressions
From the 10.06.07 until the 14.06.07 we had visitors from the
Arabian Countries Jordan and Syria with us in Bonn:
Dr. Mohammed Saleem, Sips, (left) and Dr. Nader Chaghlil, Alfares,
(right). By courtesy of the DGRA, they were invitited to attend the
anual conference. They were so impressed that Dr. Chaghlil
spontaneously decided to join the DGRA as a member.
Declaration to conflict
of interest / Fees: Since the start of my professorship at Bonn
university I am working as consultant for pharmaceutical companies in
all fields of "Regulatory Affairs" topics and am preparing
expert reports. This is to be done as a) (allowed) freelance or b) as
duty of the chair. The fees to a) I receive (taxable, incl.
value added tax (VAT)) as personal reimbursement (As of 01.01.10: hourly
rate 300,- €, reduced daily rate 2000,- € plus VAT. Minimum amount: one consultation hour per individual case. For existing contracts
the former rates remain) plus possible expenses (e.g. investigation costs
for databases) and possible travel costs. To b) the Chair receives funds
from third parties, that are managed by the University of Bonn and stated
according to their rules.
VAT No.: 215/5159/1325 VST (Finanzamt Köln-Mitte)
Please make first contact through:
The regulatory scene:
The heavily regulated market of medicinal products and
medical devices requires approvals and maintenance activities for the
manufacturing, inspections, clinical trials, marketing authorisations,
renewals and regulatory maintenance activities.
Long-term experience and competence of professionals in
(International Regulatory Affairs, Product & Device Approvals,
Pharmacovigilance & Drug Safety, Regulatory Compliance: GMP, GLP, GCP)
effectively supports the regulatory life cycle management of medicinal
products and medical devices.
Early and continuous consultation on regulatory requirements
and strategies contributes substantially to the success of Research and
Development (R&D) projects of pharmaceutical manufacturers.
With a network of globally operating partners we can offer
comprehensive services in Europe, and lots of countries in the world.
We can help you:
We offer management training in all aspects of regulatory sciences according
to your needs (including our
at the University).
(even with official partners from regulatory bodies) inspection according
the PIC/S scheme to gain GMP certificates.
development-support for new and to be reconstructed fabrication facilities
e.g. water, air etc. with experienced partners.
establish, implement and maintain viable organisational structures in
pharmaceutical R&D with regard to the principle functions of regulatory
roles, responsibilities and management accountability of regulatory
functions and staff.
the interfaces between regulatory functions and their principle
interlocutors like R&D, Manufacturing, Marketing and Legal Affairs.
We are happy to provide intelligence on important regulatory developments
We offer management training in regulatory sciences according to your needs.
We support regulatory activities during the entire life cycle of medicinal
products and medical devices:
to Development, Development, Registration, Pharmacovigilance activities
Post-marketing and Maintenance.
Our services cover regulatory activities for
(small molecules) and complex
entities derived from biotechnology and molecular biology.
We are also pleased to offer scientific consultation regarding the active
search for new active substances for potential medicinal products especially
of biological nature
GMP – Education:
In cooperation with partners we offer inspection
services (“as-if” and real) in accordance with European and international
requirements, patents, purchase/sell of application, mediation of
products/partnerships and companies.
Our experience covers all items of
drug development :
European Regulatory Assessments and Strategies Development
Prof. Dr. rer. nat. habil. Harald G. Schweim,
born in Elmshorn, Germany in 1950, married since 1973 with Ruth Schweim née
Gerdsen, two children: son Hauke (born 1977) und daughter Janna (born 1982),
studied food chemistry and pharmacy at the University of Hamburg where he
was examined in 1977. From 1978 until 1988 he was a research assistant at
that same University. His subsequent stages included habilitation, venea
legendi and private docent in Pharmaceutical Chemistry (1989), certificate
in medical informatics (1999), specialised pharmacist in drug information
(1999), and governmental public health (2001). He was associate professor at
the Free University of Berlin (1996) and at the University of Bonn (1999).
From 1992 until 1995 he was head of the licensing department for drugs at
the former Federal Health Office (BGA) in Berlin. He was director of the
Federal Institute for Medical Information and Documentation (DIMDI) in
Cologne from 1996 until 2002 and (partly held both positions) from 2000 to
2004 (since 2002 as lifetime position) President of the German Federal
Institute for Drugs and Medical Devices (BfArM). Since end of 2004 he has a
lifetime full professorship (C4) for “Drug Regulatory Affairs” at the RFW-University
of Bonn. Memberships in various scientific societies:
„Gesellschaft Deutscher Chemiker“ (GDCh); „Deutsche Gesellschaft für
Regulatory Affairs“ (DGRA)until 12/08 ; „Deutsche Pharmazeutische Gesellschaft“ (DPhG);
Drug Information Association (DIA), treasurer of the „Deutschen Gesellschaft
für Medizinische Informatik, Biometrie und Epidemiologie“ (GMDS) and "Kölner
Verein für seelische Gesundheit" (KVsG).
publications, posters and presentations as well as books or articles in
Other courses I'm teaching in:
Science in Drug Research" (M. Sc.). A new course established by Bonn
University. Details to be found here:
. My part is in module B http://www.schweim.privat.t-online.de/16386/20201.html
„Consumer Health Care“, Charité Universitätsmedizin, Berlin,
Medicine“, Brüssel, Verbund von: Autonom. Univ. Barcelona, Univ. Bonn, Chatenay-Malabry, Lillie 2 und Cath. Uni. Louvain,
„Zentrum für Arzneimittelforschung,-Entwicklung und -Sicherheit (ZAFES)“, Universität Frankfurt und bin
beteiligt an der Beantragung der Graduiertenschule „FIRST“ mit dem
Bah-Troore, pharmacist, MDRA
And 18 Ph. D. students
Permanent co-workers at the chair:
Prof. Dr. Rolf Bass, physician, former
Head of the Human Medicines Evaluation Unit at the European agency the EMEA
Dr. Helga Blasius, pharmacist and examined translator for Korean and
Dr. H. Günter Hennings,
chemist and physician
Dr. Jörg Fuchs, pharmacist, specialised on readability testing
Günter Winkmann, chemist and retrieval specialist
part-time co-workers including engineers, technologists etc.
Some of the links are in German - only
Besides the topis stated via the titles of
the dissertations my personal interst is focused on
1) off label use
2) counterfeit drugs
3) quality, effectiveness oeconomic value
of medical treatment
4) health care politics
since (German only) 2005 click
Actual presentations in foreign countries or in English
(full publication list click
und H. G. Schweim,
"Managing the Lifecycle independently from
the submission output format",
am 27.02.07 in Paris.
H.G. Schweim, "Update on European legislation after review 2004",
Jabal Amman - Third Circle,
Jordanien am 15.03.07 in Amman.
und Harald G. Schweim,
Submission Overcoming Initial Hurdles",
19th Annual EuroMeeting,
26-28 März 2007
Vanessa Plate, C. Behles und H. G. Schweim,
off-label-use in paediatrics by improving drug information
study of approvals of children’s medicines since 2001 and a database for
approved children’s medicines",
19th Annual EuroMeeting,
26-28 März 2007
und H. G. Schweim,
"Introduction to eCTD Submissions" at the Informa-Conference "Regulatory
Challenges in Central and Eastern Europe", am 17. und 18. 04.07 in Budapest.
H.G. Schweim: "European System with respect to generics" and "Inspections
and GMP", Conference on Patents and Drug Approval at
Royal Chamber of Commerce & Industry, 28 - 29.04.07, Riyadh, Kingdom of Saudi-Arabia.
"The European system of using e-submission", Presentation on invitation at
Saudi Food & Drug Authority (SFDA), at the
Kingdom of Saudi-Arabia.
und H. G. Schweim,"Electronic
Regulatory Submission (ERS) in the EU - Overview", DGRA-Anual-Kongress, at
the 12. and 13. 06. 07 in Bonn.
D. Lewinski, V.
Plate, S. Wind, C. Belgardt und H.G.
Risk Management in German Community Pharmacies: Safety-relevant Problems in
Self-Medication, International Society of Pharmacovigilance (ISOP)
Annual Meeting, 21 – 24 October 2007
in Bournemouth (UK).
H. G. Schweim,
Regulatory Affairs Submissions Management, Wyeth Europa
of Bonn, Department of „Drug Regulatory Affairs“, Germany,
To eCTD-only Submissions in the EU: Lifecycle Management
DIA Electronic Submissions, Conference
14-16th November 2007, San
and M. Saleem, "Marketing authorisation in Middle East" (Egypt, Jordan,
Oman, Saudi-Arabia, Syria, United Arab Emirates) Forum Institut, 04.Dez.
2007 in Frankfurt.
Label, Unlicensed And Compassionate Use Account For Isolated Drug
Strategies In Selected Industrial Countries", DPhG-Jahrestagung 08. -
S. Wind, C. Belgardt, V. Plate,
C. Behles and H. G. Schweim,
Prevalence and safety-relevance of
drug-related problems in German community pharmacies,
and Drug Safety,
2009 Sep 23,Abstrakt
PMID: 19777534 [PubMed].
and H. G. Schweim,
"History and mission of CADREAC and comparison of
CADREAC via national procedures",DRA-Journal, Aug. 2010
(full list of publications and
The Ph.D. students are to be found,
including the link to their "exposés" (some of them are in English),
at the German version of this
Since 2009 there have
been seven thesis finished !
Free Ph.D. students are furthermore welcome!
Topics: Counterfeit of Drugs, Drugs in the Internet,
Questions of Reimbursement and Regulations on Medicines,
Package Leaflet, Patient Information versus legal Security for the
Pharmacovigilance and Regulation, Future of traditional
Drugs, Clinical Trials, Regulatory Factors (e.g. number of test persons), Follow
up to EU-Enlargement, Adverse Drug Reactions (ADR) and Impact on Approvals,
Impact of Education/knowledge on Times of Approval, Regulation on Homoeopathics,
Law of Medical Devices – Drug Law – comparisons,
Off Label Use, a.m.m. Required is a very good or good degree in a
subject, that also allows admission to the Master Course, desirable, but
no requirement is the
MDRA. Jobs are not resp. rarely included. To whom is interested in a
dissertation in this subject, please contact me - without obligation -
by sending a short curriculum vitae with career and marks per mail (schweim(at)web.de)
for further information. The
Regulation of Dissertation is going to change soon.
The recognition of the subject "Drug Regulatory Affairs" as an
(part-)dissertation subject is approved.
At the Chair you can receive - if the necessary
personal and, partly, material requirements are fulfilled - the
Pharmacist for Drug Information", the
"Certificat Medical Informatics",
the "Physician-Medical Informatics"
and possibly the "Specialised
Pharmacist for "Gouvernmental Public Health" during
Graduating from the course
"Master of Drug Regulatory Affairs" in Bonn is often connected with career
steps, but nearly always with the fact of being member of a demanded
profession, and a safe job.
the situation will improve again after finishing a dissertation
in "Drug Regulatory Affairs", but, according to the shortage of graduates, we have no experiences on that. All colleagues, who have done a
dissertation up to now, work in
reputated positions in the pharmaceutical industry.
History of the chair :
In summer 1997 the Dres. Baccouche, Ernst
and Hofer met with me (H. G. Schweim) to take up again an old idea (that
we already discussed 10 years before): To develop the education of "Drug Regulatory
Affairs Managers" from a "learning by doing" to a science based
study course of education. We started to negotiate with several universities
about a course of study, as well as with single persons,
associations and companies about support. Happily, the University Bonn
was willing to make an attempt and we won some personal and institutional
supporters. Therefore the
Gesellschaft für Regulatorische Angelegenheiten" (a german society
has to have a german name - happily, DGRA was equally spelled as the
english abbreviation for "Deutsche Gesellschaft für
was established on
1st october 1998
in Bonn. The founding
Prof. Dr. H. G. Schweim (1.
Chairman), Dr. M. Baccouche (2. Chairman), Dr. E. Ernst (Representative for
further education and continued education), Dr. J. Hofer (treasurer)
Frau I. Ehrhart (secretary). The registration of the society with its
statutes into the official register of societies at the county court Bonn
was carried out on 14.08.1998 under the registration number 20 VR 7490.
10th and 11th june 1999 the official DGRA foundation
conference took place at the Hotel Königshof Bonn and on
1st july 1999
office was equipped.
the winter semester 1999
the first course
for "Expert" (later changed into "Master") of
Drug Regulatory Affairs started at the University Bonn with 35 students.
Already at an early time - but
considered to be utopian for a long period - we hoped to establish a
I myself always considered it to be attainable maybe within the years , 2010-2015.
Due to lucky political circumstances - and certainly because of the success
of the studying course - already in 2004 a corresponding C-4 professorship
(old determination "Chair") was established, advertised and
occupied, according the rules of the university, by me, H. G. Schweim.
professorship holds the studying course in training,
happily supported by many highly qualified experts as
lecturers from the pharmaceutical industry, gouvernmental institutions,
freelancers and university.
on the Master
Course is continuously high. Although we extended from initially 35 places
to 45, we are overbooked chronically. For the MDRA-8 to come, we had 102
qualified applications. As our success is owed not at least to the
highclass lecturers from the pharmaceutical industry, gouvernmental
institutions, private industry and universities (who are only available
time limited), it is unfortunately impossible to establish a parallel
course. Another extension of the number of admissions is likewise
impossible without a loss of quality.
information about the course are from:www.dgra.de
Please contact our Business Office if you have any
queries regarding the DGRA or the Master of Drug
Regulatory Affairs study programme at the University of
You can order
information material or
apply for membership using the online forms
on the following pages.
The Course of Studies entitled "Drug Regulatory Affairs" at
the Faculty of Mathematics and Natural Sciences of the Rhenisch
Friedrich Wilhelm University in Bonn (see also the homepage of
the University of Bonn) is a postgraduate course of studies as
defined in Clause 90 of the Act on Tertiary Educational
Institutions. It has been designed as an interdisciplinary
course covering areas of pharmaceutical sciences, law and
medicine. This selective, practical postgraduate course of
studies is intended to impart knowledge about the chemical,
pharmaceutical, pharmacological, toxicological and clinical
content of regulatory documentation and its evaluation. The aim
is also to provide information on IT, drug development, quality
assurance and quality management, pharmaceutical law in Europe
and important areas outside Europe, and on regulatory strategies.
The course of studies takes twelve months, including the
practical work. This is equivalent to two semesters. The
theoretical part of the course is taught in twelve modules of 20
to 30 hours each for a total attendance time of 320 hours. The
modules are spread across two semesters. The classes will be
taught in German or English, depending on their content.
Students are also required to complete six-month period of
practical training in the field of Drug Regulatory Affairs.
Candidates passing the examination will be awarded a
Certificate of Master of Drug Regulatory Affairs by the Faculty
of Mathematics and Natural Sciences.
with a degree in pharmacy, human medicine or veterinary medicine
or in a scientific discipline, e.g. biology or chemistry, may
apply for admission to the Master of Drug Regulatory Affairs
course of studies at the Faculty of Mathematics and Natural
Sciences of the RFW University in Bonn (see also Section 3 of
Graduates in other disciplines may be admitted in certain
circumstances. Good language skills in German and English and
basic computer skills are also required.
According to the University Law of North Rhine Westphalia,
course of further education must be self-financing. For this
reason, it is necessary to charge tuition fees. The tuition fee
is 5.112,- EURO.
The application deadline the 2006/2007 academic year is June
15, 2006. To enrol in the 2006/2007 Drug Regulatory Affairs
programme you may use the following
application form. Please complete the form on
the screen, print it out and submit it with your supporting
documents to the DGRA Head Office.
Pictur from our summer barbecue-party with Ph.D. students and guest-scientists