Harald Schweim

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!

HE XIII INTERNATIONAL CONGRESS "PHYTOPHARM 2015", 22 - 24 July 2015, Pharm. Inst. Bonn, Germany Scienific Program, Presentations and Abstracs even Photoimpressions HERE

THE XIII INTERNATIONAL CONGRESS "PHYTOPHARM 2009", 29 - 31 July 2009, Pharm. Inst. Bonn, Germany Scienific Program, Presentations and Abstracs even Photoimpressions HERE

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.

German VAT No.: 215/5159/1325 VST (Finanzamt Köln-Mitte)

Please make first contact through: schweim(at)web.de.

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 Regulatory Sciences (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 “Master course” at the University).

We organise (even with official partners from regulatory bodies) inspection according the PIC/S scheme to gain GMP certificates.

We offer development-support for new and to be reconstructed fabrication facilities e.g. water, air etc. with experienced partners.

We establish, implement and maintain viable organisational structures in pharmaceutical R&D with regard to the principle functions of regulatory sciences.

We define roles, responsibilities and management accountability of regulatory functions and staff.

We optimise 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 and trends.
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:

Discovery to Development, Development, Registration, Pharmacovigilance activities

Post-marketing and Maintenance.

Our services cover regulatory activities for traditional and new active substances (small molecules) and complex new 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 :

Global and European Regulatory Assessments and Strategies Development

Registration and other regulatory documentations and dossiers for national and international submissions e.g.:
the Common Technical Document (CTD) for
- the centralised procedure (CP) and
- decentralised or mutual recognition (DP/MRP) procedures in the EU
- new drug applications (NDA) in foreign countries
Regulatory portfolio assessment and due diligence

The „head“:

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).

More than 400 publications, posters and presentations as well as books or articles in books.

Other courses I'm teaching in:

"Master of Science in Drug Research" (M. Sc.). A new course established by Bonn University. Details to be found here: http://www.pharma.uni-bonn.de/lehre/m.-sc.-in-arzneimittelforschung-drug-research/drug-research-1?set_language=en . My part is in module B http://www.schweim.privat.t-online.de/16386/20201.html

„Consumer Health Care“, Charité Universitätsmedizin, Berlin, click title

„Eudipharm Pharmaceutical 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 Schwerpunkt Arzneimittelentwicklung/translatorische Biomedizin, Frankfurt

The direct staff:

N. 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 Japanese

Dr. H. Günter Hennings, chemist and physician

Dr. Jörg Fuchs, pharmacist, specialised on readability testing

Dr. Günter Winkmann, chemist and retrieval specialist

And several part-time co-workers including engineers, technologists etc.

Remark: Some of the links are in German - only

Research interest: 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

Publications since (German only) 2005 click here

Actual presentations in foreign countries or in English (full publication list click HERE) :

J Schnitzler 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", Jordan FDA, Jabal Amman - Third Circle, Jordanien am 15.03.07 in Amman.

Jörg Schnitzler und Harald G. Schweim, "eCTD Submission Overcoming Initial Hurdles", DIA EuroMeeting 19th Annual EuroMeeting, 26-28 März 2007 in Viennna/Austria.

Vanessa Plate, C. Behles und H. G. Schweim, Poster "Reducing off-label-use in paediatrics by improving drug information – Comparative study of approvals of children’s medicines since 2001 and a database for approved children’s medicines", DIA EuroMeeting 19th Annual EuroMeeting, 26-28 März 2007 in Vienna.

J. Schnitzler 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.

H.G. Schweim, "The European system of using e-submission", Presentation on invitation at the Saudi Food & Drug Authority (SFDA), at the 30.04.07, Riyadh Kingdom of Saudi-Arabia.

J. Schnitzler 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. Schweim, Risk Management in German Community Pharmacies: Safety-relevant Problems in Self-Medication, International Society of Pharmacovigilance (ISOP) Jahrestagung,7^th Annual Meeting, 21 – 24 October 2007 in Bournemouth (UK).

J. Schnitzler, H. G. Schweim, Global Regulatory Affairs Submissions Management, Wyeth Europa Limited, UK, University of Bonn, Department of „Drug Regulatory Affairs“, Germany, Transitioning To eCTD-only Submissions in the EU: Lifecycle Management Issues, 6th Annual DIA Electronic Submissions, Conference 14-16th November 2007, San Diego.

H.G. Schweim and M. Saleem, "Marketing authorisation in Middle East" (Egypt, Jordan, Oman, Saudi-Arabia, Syria, United Arab Emirates) Forum Institut, 04.Dez. 2007 in Frankfurt.

Plate V , Nies P, Blasius H, Schweim JK, Behles C, Schweim HG, "Off Label, Unlicensed And Compassionate Use Account For Isolated Drug Development Strategies In Selected Industrial Countries", DPhG-Jahrestagung 08. - 10.10.2008, Bonn

D. Lewinski, S. Wind, C. Belgardt, V. Plate, C. Behles and H. G. Schweim^, Prevalence and safety-relevance of drug-related problems in German community pharmacies, Pharmacoepidemiology and Drug Safety, 2009 Sep 23,Abstrakt HIER PMID: 19777534 [PubMed].

A. Herrmannand H. G. Schweim, ^"History and mission of CADREAC and comparison of CADREAC via national procedures^",DRA-Journal, Aug. 2010 angenommen.

(full list of publications and presentations click HERE)

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 site.

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 Pharamceutical Company, 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 selfstanding (part-)dissertation subject is approved.

At the Chair you can receive - if the necessary personal and, partly, material requirements are fulfilled - the "Specialised Pharmacist for Drug Information", the "Certificat Medical Informatics", the "Physician-Medical Informatics" and possibly the "Specialised Pharmacist for "Gouvernmental Public Health" during the dissertation.

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.

Probably 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

"Deutsche 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 Regulatory Affairs") was established on 1st october 1998 in Bonn. The founding committee was:

Prof. Dr. H. G. Schweim (1. Chairman), Dr. M. Baccouche (2. Chairman), Dr. E. Ernst (Representative for education, further education and continued education), Dr. J. Hofer (treasurer) and 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.

On 10th and 11th june 1999 the official DGRA foundation conference took place at the Hotel Königshof Bonn and on 1st july 1999 an official office was equipped.

In 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 corresponding professorship. 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.

The 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. Medium-term.

The request 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.

The 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 Bonn.

You can order information material or apply for membership using the online forms on the following pages.

E-Mail: info@dgra.de

STUDY AIM

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.

ADMISSION

Interested persons 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 the Examination Regulations).
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.