YOUR EXPERT
IN DRUG DEVELOPMENT
MEDICAL
MONITORING
PHARMACOVIGILANCE
QPPV
DRUG
DEVELOPMENT
QUALITY
ASSURANCE
REGULATORY
AFFAIRS
IMPRESSUM
© 2016 USCONSULTING
WHO WE ARE
Ursula founded USConsulting beginning of 2013.
Ursula Schlichtiger has more than 30 years of experience in executive positions in the Pharmaceutical Industry and CROs in the area of Drug Development. She enjoys long-lasting close relationships to EMA and other relevant regulatory bodies. Ursula holds a Medical degree (Doctorate) from the University of Graz, Austria.
USConsulting provides support in all aspects of Drug Development covering pharmaceuticals, biologicals including biosimilars as well as borderline device products. USConsulting will in particular offer assistance in ensuring that development of our client products follows all applicable regulatory requirements.
OUR NETWORK
DR. MED. URSULA SCHLICHTIGER
At USConsulting we work with a global network of experts, all with industry and CRO experience in the fields of Medical Monitoring, Pharmacovigilance (pre- and post-marketing) and Regulatory Affairs. To assure that you as our client get exact the expertise that fits your needs.
SERVICES / DRUG DEVELOPMENT
Our expertise is in the clinical development from Phase 1 to filing of the Marketing Authorisation Application and includes the interfaces with the preclinical and CMC development:
Medical Monitoring
DRUG DEVELOPMENT
Drug Development
Pharmacovigilance
+ Drug Development Plans /Concepts
Including: > Planning and Reporting of Clinical trials Phase I –Phase III > Medical Monitoring > Study related medical and safety management plans+ Scientific Advice on National and EU / EMA level+ PIPs including all aspects of pediatric development concepts+ Advisory Boards+ Scientific Due Diligence
Regulatory Affairs
Quality Assurance
REGULATORY AFFAIRS
+ Scientific Advice (national and EMA) PIP
+ EUDRACT reporting+ Government Programs+ MAAs > Modules 2.4 and 2.5
> Module 5 > Textes / labelling including national particulars
SERVICES / REGULATORY AFFAIRS
In all aspects of Regulatory Affairs we help you with our long lasting experience on a consultancy basis and also support you with operational working expertise:
Based on Ursula Schlichtiger’s long lasting experience as a physician in the pharmaceutical Industry and in CROs and together with our network of board certified specialists we cover the key areas of drug development in indications such as: metabolic diseases, cardiovascular and respiratory diseases, oncology and various other special indications in ophthalmology and ENT for small and large molecules.
Our Medical Monitoring Services include:
MEDICAL MONITORING
+ Medical Monitoring of an individual clinical trial
> Medical Monitoring Plans > training and support of investigator sites > medical review of study protocols and clinical study reports > support with eligibility questions > medical support of operational functions such as CRAs and Project Managers+ Medical Safety Monitoring > Safety Management Plans (medical input)
> SAE reviews and assessments > AE reviews > Regular safety reviews for trends and signals > DSURs
SERVICES / MEDICAL MONITORING
SERVICES / PHARMACOVIGILANCE
+ Clinical safety (pre-marketing)
> Set up of a customized safety system > Safety Management Plans > Drug Safety Officer for clinical trials > DSURs+ Post marketing Pharmacovigilance > Set up of a PV system
> PV-SOPs > PSMF > RMPs > PSURs > Preparation for PV inspections
Ursula Schlichtiger is an expert in pre- and post-marketing safety and has more than 20 years of QPPV experience for pharmaceuticals and biologicals including ATMPs. Based on this outstanding source of knowledge we offer:
PHARMACOVIGILANCE
SERVICES / QUALITY ASSURANCE
QUALITY ASSURANCE
+ Establishing a QM system
+ Vendor selection and qualification+ Inspection readiness preparation especially for MAA procedures
Though QA activities are not the main focus of our work, based on our expertise we help our clients with:
Angaben gemäß §5 TMG:
USConsulting
Dr. med. Ursula Schlichtiger
Brunnstr. 5-7
80331 Munich – Germany
Telefon: +49 (0)89 688 87 78
E-Mail: schichtiger@schlichtiger.net
www.schlichtiger.com
Umsatzsteuer-Identifikationsnummer
gemäß §27a Umsatzsteuergesetz: DE
Inhaltlich Verantwortlicher gemäß § 10 Mediendienste-Staatsvertrag (MDStV):
Dr. med. Ursula Schlichtiger
Brunnstr. 5-7
80331 Munich – Germany
Urheberrechte© 2018 Dr. med. Ursula Schlichtiger, München / Deutschland. Alle Rechte vorbehalten. Die Inhalte dieser Website sind Eigentum von Dr. med. Ursula Schlichtiger.
Jegliche Vervielfältigung oder Weiterverarbeitung in jedem Medium als Ganzes oder in Teilen bedarf der schriftlichen Zustimmung von Dr. med. Ursula Schlichtiger.
HaftungDiese Website wurde mit größtmöglicher Sorgfalt zusammengestellt. Trotzdem kann keine Gewähr für die Fehlerfreiheit und Genauigkeit der enthaltenen Informationen übernommen werden. Jegliche Haftung für Schäden, die direkt oder indirekt aus der Benutzung dieser Web-Site entstehen, wird ausgeschlossen.
Sofern von dieser Website auf Internetseiten verwiesen wird, die von Dritten betrieben werden, übernehmen wir keinerlei Verantwortung für deren Inhalte.
USCONSULTING
YOUR EXPERT
IN DRUG DEVELOPMENT
The best way to reach us is by public transport and the nearest Public Transport Stations are: Sendlinger Tor (U-Bahn): from where it is 5 minutes' walk and Karlsplatz (U-Bahn and S-Bahn) from where it is a 10 minutes' walk.
If you arrive at the Munich Airport, take the S-Bahn (S1 or S8) to Karlsplatz from where it is a 10 minutes’ walk.
We do not recommend to come by car as there is little free parking space but if you come by car the nearest Parking is: Parkhaus Pschorr Haus from which it is a 5 minutes’ walk.
Click on the map above to open Google Maps
CONTACT
schlichtiger@schlichtiger.net
YOUR WAY TO US
USConsultingDr. med. Ursula SchlichtigerBrunnstr. 5-780331 Munich – Germany
T +49 (0)89 688 87 78
M +49 (0)172 818 92 03
www.schlichtiger.com
© 2018 USCONSULTING
YOUR EXPERT
IN DRUG
DEVELOPMENT
MEDICAL MONITORING / PHARMACOVIGILANCE QPPV /
DRUG DEVELOPMET / QUALITY ASSURANCE /
REGULATORY AFFAIRS
DR. MED.
URSULA
SCHLICHTIGER
Ursula Schlichtiger has more than 30 years of experience in executive positions in the Pharmaceutical Industry and CROs in the area of Drug Development. She enjoys long-lasting close relationships to EMA and other relevant regulatory bodies. Ursula holds a Medical degree (Doctorate) from the University of Graz, Austria.
+ Drug Development Plans /Concepts
Our expertise is in the clinical development from Phase 1 to filing of the Marketing Authorisation Application and includes the interfaces with the preclinical and CMC development:
Including:
> Planning and Reporting of Clinical trials Phase I –Phase III> Medical Monitoring> Study related medical and safety management plans
+ Scientific Advice on National and EU / EMA level
+ PIPs including all aspects of pediatric development concepts+ Advisory Boards+ Scientific Due Diligence
SERVICES / REGULATORY AFFAIRS
In all aspects of Regulatory Affairs we help you with our long lasting experience on a consultancy basis and also support you with operational working expertise:
+ Scientific Advice (national and EMA) PIP
+ EUDRACT reporting+ Government Programs+ MAAs
> Modules 2.4 and 2.5
> Module 5> Textes / labelling including national particulars
> Safety Management Plans (medical input)> SAE reviews and assessments > AE reviews> Regular safety reviews for trends and signals> DSURs
> Medical Monitoring Plans> training and support of investigator sites> medical review of study protocols and clinical study reports> support with eligibility questions> medical support of operational functions such as CRAs and Project Managers
Based on Ursula Schlichtiger’s long lasting experience as a physician in the pharmaceutical Industry and in CROs and together with our network of board certified specialists we cover the key areas of drug development in indications such as: metabolic diseases, cardiovascular and respiratory diseases, oncology and various other special indications in ophthalmology and ENT for small and large molecules.
Our Medical Monitoring Services include:
+ Medical Safety Monitoring
+ Medical Monitoring of an individual clinical trial
+ Post marketing Pharmacovigilance
+ Clinical safety (pre-marketing)
> Set up of a PV system> PV-SOPs> PSMF> RMPs> PSURs> Preparation for PV inspections
PHARMACOVIGILANCE
> Set up of a customized safety system> Safety Management Plans> Drug Safety Officer for clinical trials> DSURs
SERVICES / PHARMACOVIGILANCE
Ursula Schlichtiger is an expert in pre- and post-marketing safety and has more than 20 years of QPPV experience for pharmaceuticals and biologicals including ATMPs. Based on this outstanding source of knowledge we offer:
Though QA activities are not the main focus of our work, based on our expertise we help our clients with:
+ Establishing a QM system
+ Vendor selection and qualification+ Inspection readiness preparation especially for MAA procedures
SERVICES / QUALITY ASSURANCE
YOUR WAY TO US
USConsultingDr. med. Ursula SchlichtigerBrunnstr. 5-780331 Munich – Germany
T +49 (0)89 688 87 78
M +49 (0)172 818 92 03
www.schlichtiger.com
The best way to reach us is by public transport and the nearest Public Transport Stations are: Sendlinger Tor (U-Bahn): from where it is 5 minutes' walk and Karlsplatz (U-Bahn and S-Bahn) from where it is a 10 minutes' walk.If you arrive at the Munich Airport, take the S-Bahn (S1 or S8) to Karlsplatz from where it is a 10 minutes’ walk. We do not recommend to come by car as there is little free parking space but if you come by car the nearest Parking is: Parkhaus Pschorr Haus from which it is a 5 minutes’ walk.
IMPRESSUM
Angaben gemäß §5 TMG:
USConsulting
Dr. med. Ursula Schlichtiger
Brunnstr. 5-7
80331 Munich – Germany
Telefon: +49 (0)89 688 87 78
E-Mail:
www.schlichtiger.com
Umsatzsteuer-Identifikationsnummer
gemäß §27a Umsatzsteuergesetz: DE
Inhaltlich Verantwortlicher gemäß § 10 Mediendienste-Staatsvertrag (MDStV):
Dr. med. Ursula Schlichtiger
Brunnstr. 5-7
80331 Munich – Germany
Urheberrechte© 2018 Dr. med. Ursula Schlichtiger, München / Deutschland. Alle Rechte vorbehalten. Die Inhalte dieser Website sind Eigentum von Dr. med. Ursula Schlichtiger.
Jegliche Vervielfältigung oder Weiterverarbeitung in jedem Medium als Ganzes oder in Teilen bedarf der schriftlichen Zustimmung von Dr. med. Ursula Schlichtiger.
HaftungDiese Website wurde mit größtmöglicher Sorgfalt zusammengestellt. Trotzdem kann keine Gewähr für die Fehlerfreiheit und Genauigkeit der enthaltenen Informationen übernommen werden. Jegliche Haftung für Schäden, die direkt oder indirekt aus der Benutzung dieser Web-Site entstehen, wird ausgeschlossen.
Sofern von dieser Website auf Internetseiten verwiesen wird, die von Dritten betrieben werden, übernehmen wir keinerlei Verantwortung für deren Inhalte.
ICH-E6 (GCP) Addendum (Rev2) will come into effect in autumn 2016 and will introduce Risk Based approach to the supervision of clinical trials.
EMA announces that implementation of the Clinical Trial Regulation is postponedAt the Management Board Meeting in December 2015 a further delay regarding the date when the Clinical Trial Regulation will become effective was announced as follows:
The endorsed timeframe foresees that the portal and database are planned to be available for an independent audit by August 2017. If the system receives a green light from the audit, the Clinical Trial Regulation will come into effect by October 2018 at the latest. This is a maximum timeframe, and every effort will be made to shorten it and bring the Regulation into operation as soon as possible.
For details see the Minutes of the December Management Board Meeting on the EMA webpage.
EUDRACT: posting of clinical Trial Results possible again since 14 January 2016Due to a software error detected, EUDRACT was taken offline for posting of clinical trial results in July 2015. Recent announcement now states:
The Agency has resolved the problems which led to the temporary unavailability of summary results in the EU Clinical Trial Register (EU CTR) and the withdrawal of access for sponsors to enter results or edit existing results.
In the context of clinical trial sponsors’ or PIP addressees’ ability to meet regulatory reporting timeframes, the new deadline for submission for all summary results affected by the period that the system was offline will be a date six months from the date of re-opening of the system. Affected results are those whose submission deadline fell due during the period that the system was offline, as well as those whose submission deadline falls within a period of two months from the re-opening date.