| Date |
Lecture / Presentation
|
| 2013/06/17-18 |
Revised European Guideline on Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms
Prof. Dr. Henning Blume (Scientific and Planning Committee)
EUFEPS Open Forum Discussion, Bonn
|
| 2013/05/16 |
Development of formulations with added value
Prof. Dr. Henning Blume, SocraTec R&D GmbH
AGAH Workshop "Beyond the guidelines", Bad Homburg
|
| 2013/05/16 |
Protocol development, definition of in/ex criteria and clinical conduct of BA/BE studies in patients
Dr. Frank Donath, SocraTec R&D GmbH Dr. Barbara Schug, SocraTec R&D GmbH
AGAH Workshop "Beyond the guidelines", Bad Homburg
|
| 2013/05/16 |
Pharmacokinetic and bioanalytical issues in patient studies
Dr. Cornelia Schulte Beckhausen, SocraTec CSC GmbH
AGAH Workshop "Beyond the guidelines", Bad Homburg
|
| 2013/05/16 |
Validation of pharmacodynamic methods and endpoints
Dr. Barbara Schug, SocraTec R&D GmbH
AGAH Workshop "Beyond the guidelines", Bad Homburg
|
| 2013/05/16 |
Implants and vaginally administered devices
Prof. Dr. Henning Blume, SocraTec R&D GmbH
AGAH Workshop "Beyond the guidelines", Bad Homburg
|
| 2013/05/16 |
How to substitute efficacy/safety studies by PD analysis in locally applied / locally acting drugs
Prof. Dr. Henning Blume, SocraTec R&D GmbH
AGAH Workshop "Beyond the guidelines", Bad Homburg
|
| 2013/04/25-27 |
Biosimilars concepts for therapeutic antibodies.
Prof. Dr. Henning Blume, SocraTec R&D GmbH
PK/ PD Expertentreffen 2013, Friedewald
|
| 02/+26/25 |
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Interactive AGAH Workshop "Pragmatic approaches to paediatric medicines development"
|
| 2012/09/21 |
Phase-I-studies with newly developed liposomal formulations: safety and efficacy issues
Dr. Barbara Schug, SocraTec R&D GmbH
AGAH Workshop on liposomal formulations, Bonn
|
| 2012/09/21 |
Liposomal i.v. preparations: rationale for development & characterization
Prof. Dr. Henning Blume, SocraTec R&D GmbH
AGAH Workshop on liposomal formulations, Bonn
|
| 2012/06/04-06 |
CHMP Guideline on Bioanalytical Method Validation
Prof. Dr. Henning Blume, SocraTec R&D GmbH
3rd International Regulatory Workshop on A to Z on Bioequivalence, Budapest, Hungary
|
| 2012/03/17 |
Opioid-Retardarzneimittel: warum ist die Galenik so bedeutsam?
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Deutscher Schmerztag, Frankfurt
|
| 2012/03/01-02 |
BE and ADME studies in oncological patient populations
Dr. Barbara Schug, SocraTec R&D
22th AGAH Annual Meeting, Leipzig
|
| 2012/02/28 |
Generating meaningful clinical information: impact of/on early formulation development
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Capsugel Symposium "De-risking Drug Development", Copenhagen
|
| 2012/02/10 |
Pharmacokinetics meets biopharmaceutics: rationale for "chrono-adjusted" pharmacotherapy
Prof. Dr. Henning Blume
Symposium, Ankara
|
| 2012/02/3 |
Generische Substitution: ist ein Austausch mit therapeutischen Risiken verbunden?
Prof. Dr. Henning Blume, SocraTec R&D GmbH
mundiCampus: Wissen, das wirkt, Limburg
|
| 2011/12/12 |
Verhalten von Retardarzneimitteln im Magen-Darm-Trakt: Bedeutung & Interpretation von Food-effects
Prof. Dr. Henning Blume, SocraTec R&D GmbH
AGES Seminar, Wien
|
| 2011/12/10 |
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Seminar, Wien
|
| 12/-3/2 |
Prof. Dr. Henning Blume, SocraTec R&D GmbH
|
| 12/-2/1 |
Revised European BE Guideline: major changes-new challenges?
Prof. Dr. Henning Blume, SocraTec R&D GmbH
2nd, Bioequivalence Forum, Prague
|
| 11/-30/28 |
Draft reflection paper on guidance for laboratories analysing or evaluating clinical trial samples
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Workshop, Ulm
|
| 11/-30/28 |
CHMP Guideline on Bioanalytical method validation
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Workshop, Ulm
|
| 2011/11/19 |
Prof. Dr. Henning Blume
mundiCampus: Schmerz-Forum, Berlin
|
| 2011/11/18 |
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Innovationsforum der DGS 2011, Darmstadt
|
| 2011/11/12 |
Einfluss der Physiologie des Magen-Darm-Traktes auf die Resorption von Arzneimitteln
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Seminar, LAK, Kiel
|
| 2011/11/12 |
Biopharmazie: Einfluss der Arzneimittelform auf die Arzneimittelwirkung
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Seminar, LAK, Kiel
|
| 2011/10/25 |
European Perspective for Fixed Dose Combinations
Prof. Dr. Henning Blume, SocraTec R&D
Jahrestagung der AAPS, Washington DC
|
| 2011/10/12 |
BE studies in patient populations - new challenges and future trends
Prof. Dr. Henning Blume, SocraTec R&D GmbH
Symposium "New Regulatory Developments in Pharmacokinetic Assessment", Lissabon
|
| 2011/06/01 |
DPP-4 Inhibitoren: ein Vergleich aus pharmakologischer Sicht
Prof. Dr. Henning Blume, SocraTec R&D
Symposium "Inkretine", Leipzig
|
| 2011/05/24 |
Enhanced PD/clinical outcome through optimizing drug delivery
Prof. Dr. Henning Blume, Socra Tec R&D
1st Open Forum Biopharmaceutics and Supergenerics Budapest, Hungary
|
| 05//7/6 |
Prof. Dr. Henning Blume SocraTec R&D
|
| 2011/04/04 |
Clinical Trials for Line Extension, Added Value Generics and Novel Drug Delivery Systems
Prof. Dr. Henning Blume, SocraTec R&D
Bangabandhu International Conference Centre Agargaon, Bangladesh
|
| 2011/04/03 |
Bioequivalence and/or Therapeutic Equivalence for Generics - not by choice, but must!
Prof. Dr. Henning Blume, SocraTec R&D
Bangabandhu International Conference Centre Agargaon, Bangladesh
|
| /01/03/31 |
Example for an early drug-device development plan
Dr. Barbara Schug, SocraTec R&D
20th AGAH Anniversary, Berlin
|
| 02//24/23 |
Food effect studies: influence of population characteristics and standardisation of clinical procresses.
Dr. Barbara Schug, SocraTec R&D
EUFEPS, Barcelona
|
| 2011/02/02 |
Prof. Dr. Henning Blume, SocraTec R&D
AGAH, Bonn
|
| 2011/02/02 |
Prof. Dr. Henning Blume, SocraTec R&D
AGAH, Bonn
|
| 2010/11/13 |
Selection of reference product in bioequivalence studies for submission to multiple jurisdictions
Prof. Dr. Henning Blume, SocraTec R&D
Pharmaceutical Science World Congress, New Orleans
|
| 07/-02/01 |
Drug Delivery Technologies to optimize the clinical application of drugs
|
| 2010/06/22 |
Major Differences beetwen EMA, FDA and WHO Guidances in BE and BCS
Prof. Dr. Henning Blume, SocraTec R&D
Hungarian Academy of Sciences Budapest, Hungary
|
| 2010/06/21 |
Prof. Dr. Henning Blume, SocraTec R&D
Hungarian Academy of Sciences Budapest, Hungary
|
| 2010/06/11 |
Bioequivalence regulations for modified release products: necessity of single dose fasted, food effect & multiple dose studies
Prof. Dr. Henning Blume, SocraTec R&D
Health Canada, Scientific Advisory Committee Meeting, Ottawa/ Canada
|
| 2010/03/20 |
Pharmako-therapeutische Schmerzkontrolle: Besonderheiten unterschiedlicher Applikationswege
Prof. Dr. Henning Blume, SocraTec R&D
Deutscher Schmerztag, Frankfurt/Main
|
| 2010/03/18 |
Prof. Dr. Henning Blume, SocraTec R&D
Deutscher Schmerztag, Frankfurt/Main
|
| 2010/03/10 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2010/02/22 |
Modern Strategies for the Development of Gerneric Drugs: Highly Variable Drugs: Mechanisms for High Variability and Resolutions to Overcome the Differences
Prof. Dr. Henning Blume, SocraTec R&D
20th AGAH Annual Meeting, Hamburg
|
| 2010/02/22 |
Modern Strategies for the Development of Gerneric Drugs: Locally Acting/ Locally Applied Drug Products: APlaying Field for Human Pharmacologists?
Dr. Barbara Schug, SocraTec R&D
20th AGAH Annual Meeting, Hamburg
|
| 2010/02/04 |
BA/BE - important link between drug quality and efficacy/safety
Prof. Dr. Henning Blume, SocraTec R&D
European Regulatory Affairs Course, Oegstgeest/Niederlande
|
| 2009/11/14 |
Before or after a meal? impact of administration conditions on clinical efficacy
Prof. Dr. Henning Blume, SocraTec R&D
Peking/China
|
| 2009/06/29 |
Different salts of a pro-drug: more restrictive BE requirements?
Prof. Dr. Henning Blume, SocraTec R&D
Paris/Frankreich
|
| 06//15/14 |
Food effect studies: towards science driven regulations
Prof. Dr. Henning Blume, SocraTec R&D
2nd JAPM Bioequivalence Conference, Amman/Jordanien
|
| 2009/06/11 |
Drugs mainly taken by the elderly: BE testing in the target population?
Dr. Barbara Schug, SocraTec R&D
PharmSciFair, Nizza
|
| 2009/06/11 |
The class war: The problem of combining BCS Class I and III in biowaivers
Prof. Dr. Henning Blume, SocraTec R&D
PharmSciFair, Nizza
|
| 2009/03/29 |
BE of modified release products: difficult eytrapolation from in-vitro
Prof. Dr. Henning Blume, SocraTec R&D
Goa/India
|
| 01//15/14 |
Bioavailability/ bioequivalence: development of international regualtory requirements
Prof. Dr. Henning Blume, SocraTec R&D
EUFEPS Conference, Bonn
|
| 2008/12/05 |
BCS-based Biowaivers
Prof. Dr. Henning Blume, SocraTec R&D
Novartis Workshop on BA/BE & IVIVC, Basel/Schweiz
|
| 2008/12/02 |
Use of BCS in product development: Background - Concept - Perspective
Prof. Dr. Henning Blume, SocraTec R&D
HRMA Symposium, London/ U.K.
|
| 2008/12/02 |
Therapeutische Optimierung durch innovative Arzneiformen?
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2008/12/02 |
Dr. Barbara Schug, SocraTec R&D
|
| 2008/11/27 |
Phase-I-Studien: Wie werden die Anforderungen und Schnittstellen effizient vereinbart?
Dr. Barbara Schug, SocraTec R&D
|
| 11//07/05 |
BA/BE studies with MR products: a European perspective
Prof. Dr. Henning Blume, SocraTec R&D
ALiMS Symposium on BA/BE studies, Vrsac/Serbien
|
| 2008/ 10/23 |
Survey of International Bioequivalence requirements
Prof. Dr. Henning Blume, SocraTec R&D
Bio-International 2008, Towards improved harmonization in regulating multisource products, London
|
| 2008/10/22 |
Bioequivalence regulations: Survey of international requirements
Prof. Dr. Henning Blume, SocraTec R&D
BIO-international 08 Conference, London
|
| 10//13/12 |
Seminar: Bioavailability/bioequivalence and In-vitro dissolution
Prof. Dr. Henning Blume, SocraTec R&D
PTI Training Course, Amman/Jordanien
|
| 2008/10/09 |
Aut-idem-Substitution: sind Analgetika zur Therapie chronischer Schmerzen einfach austauschbar ?
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2008/10/08 |
Highly variable drugs: how to solve significant problems assessing bioequivalence
Prof. Dr. Henning Blume, SocraTec R&D
IRR Conference, Prag
|
| 2008/10/05 |
Bioequivalence regulations - bar or driving force for progress in science and technology?
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2008/09/11 |
Biosimilars - how similar is similar?
Prof. Dr. Henning Blume, SocraTec R&D
VIB Symposium, Berlin
|
| 2008/09/06 |
Prof. Dr. Henning Blume, SocraTec R&D
Thieme Expertentreffen, Stuttgart
|
| 2008/09/02 |
Prof. Dr. Henning Blume, SocraTec R&D
Euroforum, Frankfurt
|
| 2008/06/26 |
Therapeutische Optimierung durch innovative Arzneiformen?
Prof. Dr. Henning Blume, SocraTec R&D
Dresden
|
| 2008/06/24 |
Charakterisierung der In-vitro-Freisetzung fester oraler Darreichungsformen
Prof. Dr. Henning Blume, SocraTec R&D
Jena
|
| 2008/06/23 |
Revision of CPMP Note for Guidance on BA/BE: regulatory and scientific rationale
Prof. Dr. Henning Blume, SocraTec R&D
Jena
|
| 2008/06/18 |
Orodispersible tablets: necessity to investigate fed and fasted intake?
Prof. Dr. Henning Blume, SocraTec R&D
EUFEPS Conference, Bad Homburg
|
| 2008/06/17 |
BCS-based biowaiver: extension to Class-III drugs?
Prof. Dr. Henning Blume, SocraTec R&D
EUFEPS Conference, Bad Homburg
|
| 2008/05/13 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2008/05/12 |
Development of Super-generic: new chances for old drugs?
Prof. Dr. Henning Blume, SocraTec R&D
SMI Conference, London
|
| 2008/05/07 |
Prof. Dr. Henning Blume, SocraTec R&D
Deutsche Pharmazeutische Gesellschaft, Bonn
|
| 2008/04/30 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2008/04/21 |
Impact of product quality on the treatment with alpha-lipoic acid
Prof. Dr. Henning Blume, SocraTec R&D
Annual Conference Argentinian Diabetes Society, Buenos Aires
|
| 2008/04/08 |
Austauschbarkeit von Antiepileptika - pro und contra
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2008/03/18 |
BA/BE studies with modified release products - a European perspective
Prof. Dr. Henning Blume, SocraTec R&D
FATUM Workshop on BA/BE, Istanbul
|
| 2008/03/05 |
Revision of the CPMP Note for Guidance on BA/BE: impact on the development of generic medicinal products?
Prof. Dr. Henning Blume, SocraTec R&D
Annual Conference DIA Europe, Barcelona
|
| 2008/02/08 |
Food effect studies: towards science driven regulations
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2007/12/04 |
New Therapeutic Entities: novel biopharmaceutical concepts for improved clinical efficacy
Prof. Dr. Henning Blume, SocraTec R&D
Egalet-Sympposium, Copenhagen
|
| 2007/11/20 |
Successfully performing bioavailability/bioequivalence studies for modified release products
Prof. Dr. Henning Blume, SocraTec R&D
IRR Symposium on BA/BE, Berlin
|
| 2007/11/11 |
Prof. Dr. Henning Blume, SocraTec R&D
Jahrestagung der Schele-Gesellschaft, Binz
|
| 2007/11/10 |
Pharmakologische Bewertung oraler Antidiabetika
Prof. Dr. Henning Blume, SocraTec R&D
MSD Symposium, Berlin
|
| 2007/11/07 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2007/10/27 |
Iontophorese und postoperative Schmerztherapie
Prof. Dr. Henning Blume, SocraTec R&D
Schmerzkongress, Berlin
|
| 2007/10/01 |
Site dependent drug absorption and impact on BA/BE assessment
EUFEPS & COST B25 Conference on Bioavailability (BA) and Bioequivalence (BE): Focus on Physiological Factors and Variability, Athens/Greece
|
| 2007/10/01 |
Assessment of intestinal and hepatic first-pass: Necessity to measure metabolites?
Prof. Dr. Henning Blume, SocraTec R&D
EUFEPS & COST B25 Conference on Biovailability (BA) and Bioequivalence (BE): Focus on Physiological Factors and Variability, Athens/Greece
|
| 2007/05/23 |
Optimising GI absorption of modified release products
Prof. Dr. Henning Blume, SocraTec R&D
Dissolution Testing, Bioavailability & Bioequivalence, Budapest/Hungary
|
| 2007/05/04 |
Therapeutische Optimierung durch galenische Modifizierung?
Prof. Dr. Henning Blume, SocraTec R&D
12. Expertentreffen Pharmakokinetik/Pharmakodynamik, Heppenheim
|
| 2007/04/26 |
The need for and approaches to a European healthy volunteer database
Dr. Barbara Schug, Annick Peremans, Dr. Yves Donazzolo
Second Joint Annual Meeting Club Phase I and AGAH, Bad Homburg
|
| 2007/04/24 |
Life Cycle Management: new chances for old drugs
Prof. Dr. Henning Blume, SocraTec R&D
Pharmaceutical Sciences World Congress, Amsterdam/the Netherlands
|
| 2006/11/14 |
Optimierte Arzneiformen zur Verbesserung der Pharmakotherapie beim alten Menschen
Prof. Dr. Henning Blume, SocraTec R&D
Deutsche Pharmazeutische Gesellschaft, Frankfurt am Main
|
| 2006/10/27 |
Gastro-intestinal transit of solid oral dosage forms: imaging studies using Magnetic Marker Monitoring technique
Prof. Dr. Henning Blume, SocraTec R&D
American Academy of Clinical Pharmacy, St. Louis/MO, U.S.A.
|
| 2006/10/12 |
Hightech in der Schmerztherapie: therapeutische Optimierung durch osmotisch gesteuerte Retardform
Prof. Dr. Henning Blume, SocraTec R&D
Deutscher Schmerzkongress 2006, Berlin
|
| 2006/09/20 |
Bioavailability and bioequivalence studies for modified release products
Prof. Dr. Henning Blume, SocraTec R&D
Conference on Dissolution, Bioavailability & Bioequivalence, Prag/Tschechische Republik
|
| 2006/09/12 |
Modified release oxcarbazepine: challenges and successful development
Prof. Dr. Henning Blume, SocraTec R&D
8th EILAT Conference, Sitges/Spanien
|
| 2006/09/08 |
Leitsubstanzen in der Arzneitherapie: Konflikt zwischen Wirtschaftlichkeit und Innovationen?
Prof. Dr. Henning Blume, SocraTec R&D
Pharmakotherapie-Workshop 2006, Mainz
|
| 2006/04/01 |
Innovation oder Scheininnovation: welche Rolle spielt die Arzneiform?
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2006/03/13 |
Schlucken oder Kleben - biopharmazeutische Antworten auf eine therapierelevante Frage
Prof. Dr. Henning Blume, SocraTec R&D
Deutscher Schmerztag, Frankfurt am Main
|
| 2006/03/10 |
Prof. Dr. Henning Blume, SocraTec R&D
Interpharma "Pharmazeutische Horizonte", Frankfurt am Main
|
| 2006/03/08 |
Prof. Dr. Henning Blume, SocraTec R&D
Presseseminar, Ulm
|
| 2006/02/19 |
Drug Interaction Studies: The rational selection of drug interaction studies
Dr. Barbara S. Schug, SocraTec R&D
|
| 2006/02/10 |
Once daily nifedipine products: are they really interchangeable
Prof. Dr. Henning Blume, SocraTec R&D
Symposium "Hypertension and Calcium-antagonists", Cartagena, Kolumbien
|
| 2005/12/13 |
Fentanyl-Pflaster - eine therapeutische Bereicherung
Prof. Dr. Henning Blume, SocraTec R&D
Presseseminar, Berlin
|
| 2005/10/24 |
Bioavailability/bioequivalence: practise and issues
Prof. Dr. Henning Blume, SocraTec R&D
Bio-international 2005 Conference, London, U.K.
|
| 2005/10/18 |
Single vs. multiple dose Studien: Standards und Besonderheiten
Dr. Barbara S. Schug, SocraTec R&D
Seminar, SocraTec-CSC, Frankfurt am Main
|
| 2005/10/18 |
Dr. Barbara S. Schug, SocraTec R&D
Seminar, SocraTec-CSC, Frankfurt am Main
|
| 2005/10/18 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2005/10/01 |
Prof. Dr. Henning Blume, SocraTec R&D
Fortbildungskongress, Chemnitz
|
| 2005/09/22 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2005/09/15 |
New perspectives for added-value generics?
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2005/07/15 |
Prof. Dr. Henning Blume, SocraTec R&D
14. Klinisch-pharmakologisches Kolloquium, Biberach
|
| 2005/06/10 |
BA/BE - an important link between drug quality and efficacy/safety
Prof. Dr. Henning Blume, SocraTec R&D
European Regulatory Affairs Course, Zeist, The Netherlands
|
| 2005/05/31 |
Magen-Darm-Therapeutika: warum ist die Arzneiform so bedeutsam?
Prof. Dr. Henning Blume, SocraTec R&D
Deutsche Pharmazeutische Gesellschaft, LAK Hessen, Frankfurt am Main
|
| 2005/03/16 |
Properties of special populations
Dr. Barbara S. Schug, SocraTec R&D
AGAH Jahrestagung, Strasbourg
|
| 2005/03/12 |
Dr. Barbara S. Schug, SocraTec R&D
Wissenschaftliches Symposium AWD, Dresden
|
| 2005/01/21 |
Prof. Dr. Henning Blume, SocraTec R&D
Symposium "Rechtsfragen zu Generika", PMI-Verlag, Frankfurt am Main
|
| 2004/11/22 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2004/11/22 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2004/11/22 |
Dr. Barbara S. Schug, SocraTec R&D
|
| 2004/11/22 |
Dr. Barbara S. Schug, SocraTec R&D
|
| 2004/11/18/19 |
Designing and Evaluating BA/BE studies in the 21st Century
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2004/11/16 |
Arzneimittel F&E heute: Wiederentdeckung der Arzneiform
Prof. Dr. Henning Blume, SocraTec R&D
SocraTec-Seminar "Life-Cycle-Management", Erfurt
|
| 2004/11/16 |
Therapeutische Optimierung: nicht denkbar ohne klinische Rationale
SocraTec-Seminar "Life-Cycle-Management", Erfurt
|
| 2004/11/16 |
Proof of Concept: Stellenwert von PD-Studien und Surrogatparametern
Dr. Barbara S. Schug, SocraTec R&D
SocraTec-Seminar "Life-Cycle-Management", Erfurt
|
| 2004/11/13 |
Prof. Dr. Henning Blume, SocraTec R&D
|
| 2004/11/05 |
Dr. Barbara S. Schug, SocraTec R&D
Weiterbildungsseminar der Landesapothekerkammer Hessen, Eschborn
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