Slider 1
Pharmakovigilanz Dienstleister
VigiPRO® GmbH
Fliederstr. 15
D-42109 Wuppertal
Germany
Telefon:
Telefax:
eMail-Adresse: info@vigipro.de
Web: vigipro.de
Slider 2

VigiPRO® GmbH
Fliederstr. 15
D-42109 Wuppertal
Germany

eMail-Adresse: info@vigipro.de
Web: vigipro.de
Pharmakovigilanz, Arzneimittelsicherheit, QPPV, Stufenplanbeauftragter, Informationsbeauftragter

SERVICE

  • PHARMACOVIGILANCE-BASICS
     
  • PHARMACOVIGILANCE IN
    STUDIES
  • PHARMACOVIGILANCE-AUDITS
    / INSPECTIONS
  • QUALITY ASSURANCE
    (GVP, GDP)
  • RESPONSIBLE PERSONS
    / QPPV
  • RISK-MANAGEMENT-SYSTEMS
     
  • REPORTS
     
  • LITERATURE-SCREENING
     
  • STRATEGIC CONSULTING
     
  • START-UP CONSULTING
     
  • INTERIMS-MANAGEMENT
     
  • CLIENTS, PARTNERS
    AND CONTACTS
PHARMACOVIGILANCE-BASICS
 
  • Implementation of National and European pharmacovigilance requirements
  • Creation / revision of the PSMF
    (Pharmacovigilance System Master File)
  • Changes and reorganisation in case of
    - Outsourcing
    - Mergers and Acquisitions
    - Process optimization
  • Pharmacovigilance contracts and safety data exchange agreements (SDEA)
  • Regulatory intelligence

PHARMACOVIGILANCE IN
STUDIES
  • Medical single assessment
  • Data management
  • Evaluation of cumulative data / listings (reconciliation)
  • Periodic reports (see “Reports”)
  • MedDRA Coding

PHARMACOVIGILANCE-AUDITS
/ INSPECTIONS
  • Pharmacovigilance audits of entire pharmacovigilance systems or parts thereof
  • Audits of partners and service providers nationally and internationally
QUALITY ASSURANCE
(GVP, GDP)
  • Creation / revision of the quality assurance system according to:
    - Good pharmacovigilance practice (GVP)
    - Good distribution practice (GDP)
  • Creation / revision of quality documents (SOPs, WIs)
  • Process description and -optimization
  • Management of changes, deviations, corrective and preventive actions (CAPA)
  • SOP-trainings and pharmacovigilance trainings
  • Preparation of and support during pharmacovigilance inspections

RESPONSIBLE PERSONS
/ QPPV
  • Temporary or permanent assumption of the function / deputy:
    - EU QPPV (GVP module I, I.C.1.3)
    - Medically trained person (Regulation (EU) No. 520/2012 Art. 10 (1))
    - Graduated Plan Officer (§ 63a AMG)
    - Medical Information officer (§ 74a AMG)
    - Responsible person for narcotic drugs (§ 5 BtMG)
  • Guaranteed 24-hours-availability within the scope of the functions

RISK-MANAGEMENT-SYSTEMS
 
  • Creation/ revision of Risk-Management plans
  • Benefit- / Risk-assessment of medicinal products
  • National and European risk procedures (emerging safety issue, referral procedure)
  • Risk minimisation measures
  • Creation and implementation of "educational material”
  • Signal detection
  • Signal evaluation and documentation

REPORTS
 
  • Creation of periodic reports
    - Periodic safety update reports (PSUR)
    - Periodic benefit-risk evaluation reports (PBRER)
    - Development safety update reports (DSUR)
LITERATURE-SCREENING
 
  • Periodic literature screening
    - Global (Medline, Embase)
    - locally in German speaking countries
    - locally in further 40 countries in and outside the EU
STRATEGIC CONSULTING
 
  • Mergers and acquisitions in pharmacovigilance
  • Optimisation and modification of the
    - Pharmacovigilance System
    - Risk Management System
    - Quality Management System
  • Process optimization
  • In- and Outsourcing / Integration of service providers

START-UP CONSULTING
 
  • Regulatory consulting and support for Start-ups in the pharmaceutical sector
    (e.g. cannabis wholesalers and manufacturers)
  • Contact with authorities and license applications
  • Procurement and recommendation of service providers
  • Monitoring of the contract implementation
  • Process development and documentation

INTERIMS-MANAGEMENT
 
  • Bridging of personnel shortage
  • Assumption of pharmacovigilance functions including management positions
  • Responsible persons with deputy

CLIENTS, PARTNERS
AND CONTACTS
  • Pharmaceutical companies
  • Specialised service providers nationally and internationally
  • IT-developers, programmers and database manufacturers (Safety-Database, XEVMPD)
  • Physicians and pharmacists
  • Industry associations
  • Authorities
  • Specialised lawyers and -consultants
…and an extensive network of experts in the fields of pharmacovigilance and regulatory affairs

PHARMAKOVIGILANZ-BASICS: Umsetzung von nationalen und europäischen Pharmakovigilanz-Anforderungen,
Neuerstellung / Überarbeitung des PSMF (Pharmacovigilance System Master File),
Änderungen und Umorganisation bei:
– Outsourcing
– Verkäufen und Übernahmen
– Prozessoptimierung
Pharmakovigilanz-Verträge und -Austauschvereinbarungen, Regulatory intelligence
PHARMAKOVIGILANZ IN STUDIEN(GVP, GDP): Medizinische Einzelfallbewertung
Datenmanagement, Auswertung kumulativer Daten / Listings, (Rekonzilierung), Periodische Berichte (siehe „Berichte“), MedDRA-Kodierung
PHARMAKOVIGILANZ-AUDITS / INSPEKTIONEN: Pharmakovigilanz-Audits von gesamten Pharmakovigilanz-Systemen oder Teilbereichen, Audits von Partnern und Dienstleistern im In- und Ausland
QUALITÄTSSICHERUNG (GVP, GDP): Neuerstellung / Überarbeitung des Qualitätssicherungs-Systems entsprechend:
– Good pharmacovigilance practice (GVP)
– Good distribution practice (GDP)
Neuerstellung / Überarbeitung qualitätsgesicherter Dokumente (SOPs, WIs), Prozessbeschreibung und -optimierung, Management von Änderungen, Abweichungen, Korrektur- und Vorbeugemaßnahmen (CAPA), SOP-Schulungen und Pharmakovigilanz-TrainingsVorbereitung und Begleitung von Pharmakovigilanz-Inspektionen
VERANTWORTLICHE PERSONEN / QPPV: Zeitweise oder dauerhafte Übernahme der Funktionen / Stellvertreter:
– EU QPPV (GVP module I, I.C.1.3)
– Medically trained person (Regulation (EU) No 520/2012 Art. 10 (1))
– Stufenplanbeauftragter (§ 63 a AMG)
– Informationsbeauftragter (§ 74 a AMG)
– Betäubungsmittelverantwortlicher (§ 5 BtmG)
Guaranteed 24-hours-availability within the scope of the functions
RISIKOMANAGEMENT-SYSTEM: Neuerstellung / Überarbeitung von Risikomanagementplänen, Nutzen- / Risikobewertung von Arzneimitteln, Nationale und europäische Risikoverfahren (Stufenplan, Referral procedure), Risikominimierende Maßnahmen, Erstellung und Umsetzung von „educational material“, Signal-Detektion, Signalbewertung und Dokumentation
BERICHTE: Erstellung periodischer Berichte
– Periodic safety update reports (PSUR)
– Periodic benefit-risk evaluation reports (PBRER)
– Development safety update reports (DSUR)
LITERATURRECHERCHE: Regelmäßige Literaturrecherche
– Global (Medline, Embase)
– Lokal in deutschsprachigen Ländern
– Lokal in weiteren 40 Ländern in und außerhalb der EU
STRATEGISCHE BERATUNG: Mergers und Acquisitions in der Pharmakovigilanz, Optimierung und Änderung des
– Pharmakovigilanz-Systems
– Risikomanagement-Systems
– Qualitätssicherungs-Systems
Prozessoptimierung, In- und Outsourcing / Einbindung von Dienstleistern
START-UP BERATUNG: Regulatorische Beratung und Begleitung von Neugründungen im Pharmabereich, (z.B. Cannabis-Großhändler und -hersteller), Behördenkontakte und Anträge, Vermittlung und Empfehlung von Dienstleistern, Begleitung der Vertragsabwicklung, Prozessentwicklung und –dokumentation
INTERIMS-MANAGEMENT: Überbrückung von Personalengpässen, Übernahme von Pharmakovigilanz-Funktionen einschließlich Managementpositionen, Verantwortliche Personen mit Stellvertreter
KUNDEN, PARTNER UND KONTAKTE: Pharmaunternehmen, Spezialisierte Dienstleister im In- und Ausland, IT-Entwickler, Programmierer und Hersteller von Datenbanken (Safety Datenbank, XEVMPD), Ärzte und Apotheker, Industrieverbände, Behörden, Spezialisierte Rechtsanwälte und -berater, … und ein umfangreiches Experten-Netzwerk aus den Bereichen Pharmakovigilanz und Zulassung.

YOUR ADVANTAGE

YOUR ADVANTAGE

 

We attach great importance to loyalty, fairness, discretion and respect for our clients.

 

This results in our values and your advantages:

 

  • Professionalism - You bring expert knowledge and experience into your company.
  • Personal contact - You have ONE contact person for your project.
  • Availability - We are directly available for you and react quickly, reliably and flexibly.
  • Quality - Our services and work results are subject to our own transparent quality management system.
  • Extensive, specialised support - You benefit from our cooperation with carefully selected partners nationally and internationally. Therefore we have a solution for (almost) every pharmaceutical task.
  • Modern and up-to-date - We always have up-to-date hardware and software and use state-of-the-art media for the exchange of information and data. Data security is of particular importance. You save time and personnel resources - efficiency that pays off for you.

 

VITA

"Pharmacovigilance is a matter of trust," the founders of VigiPRO say.

<span class='hid'>Anette Sonntag</span>
<span class='hid'>Dr. med. Axel Jansink</span>
<span class='hid'>Anette Sonntag</span>

Anette Sonntag

Anette Sonntag

+ As a pharmacist with now 20 years ...
of professional experience, Ms. Anette Sonntag started her first permanent position in the local pharmacovigilance department of one of the 10 largest pharmaceutical companies worldwide in 2002 after 5 years of studies in pharmacy.

+ Until the end of 2009, ...
she worked for medium-sized and large pharmaceutical subsidiaries and headquarter companies with worldwide responsibility for pharmacovigilance activities of innovative drugs.

+ In 2010 the first contract as a freelancer followed.
Start as a freelance pharmacovigilance expert for one of the world's largest researching pharmaceutical companies in her main job.

+ Since mid-2019 Anette Sonntag has been the founder
and managing director of VigiPRO GmbH.

<span class='hid'>Dr. med. Axel Jansink</span>

Dr. med. Axel Jansink

Dr. med. Axel Jansink

+ As a physician with now 20 years ...
of professional experience, Dr. med. Axel Jansink started his first permanent position in the local pharmacovigilance department of one of the largest German pharmaceutical companies in private hands in 2003 after 4-5 years of clinical work. After less than 2 years, he took over the management of the pharmacovigilance department and the responsibility as Graduated plan officer.

+ Until the end of 2016, he worked ...
for small, medium and large pharmaceutical companies and specialized service providers in management positions as head of the global pharmacovigilance department and EU-QPPV, as pharmacovigilance project manager and graduated plan officer, head of medical affairs/pharmacovigilance and as the person responsible for all safety activities of an innovative drug worldwide.

+ In 2014, the first contract as a freelancer followed.
Start as a freelance- pharmacovigilance expert and graduated plan officer for an American pharmaceutical- and biotech company in part-time.

+ Since 2016 Dr. Jansink ...
has been working full-time as an independent consultant.

+ Since mid-2019 Dr. Jansink ...
has been the founder and managing director of VigiPRO GmbH.

REFERENCES

REFERENCES

Here is an excerpt of our satisfied clients:

 

+ Update of the quality assurance system
Revision and creation of the pharmacovigilance-SOPs, the PSMF, pharmacovigilance-contracts and -exchange agreements. Client: German affiliate company of an international pharmacovigilance- and regulatory consulting company.

+ EU-QPPV / Graduated Plan Officer for ...
a marketing authorisation holder and distributor of homeopathic medicinal products.

+ Graduated Plan Officer for ...
multiple American pharmaceutical- and biotech companies and for various pharmaceutical and specialty pharmaceutical companies from France, Great Britain, Israel, etc.

+ Pharmacovigilance in non-interventional ...
studies for one of the world's largest researching pharmaceutical companies.

+ Lead pharmacovigilance auditor for ...
a marketing authorisation holder, active substance- and drug manufacturer located in Germany.

+ Medically Trained Person for ...
a marketing authorisation holder and manufacturer of medical gases.

+ Creation of PSMF for ...
a marketing authorisation holder and manufacturer of medical gases.

+ Patient Safety Specialist for ...
one of the 5 largest researching pharmaceutical companies in the world.

+ GVP-/GDP-Regulatory Consultant for ...
a pharmaceutical start-up.

+ Medical Writing for ...
a global pharmacovigilance service provider.

+ Contractual services for ...
training, medical consulting, data entry into pharmacovigilance databases, etc.

 

 

 

CONTACT

Fliederstr. 15
D-42109 Wuppertal
Germany

 

Legal Disclosure

VigiPRO


VigiPRO® GmbH
Fliederstr. 15
D-42109 Wuppertal
Germany

 

Telephon: +49 (0) 202 2585 9181 or +49 (0) 202 2585 9185
Fax: +49 (0) 202 75 25 87
E-Mail address: info[at]vigipro.de
Internet adress: vigipro.de

 

Represented by
Dr. Axel Jansink (Managing Director), Anette Sonntag (Managing Director)

VAT indentification number in accorance with Section 27 a of the German VAT act: DE323770127

 

Konzeption, Design und Layout:
Dipl. Designerin Yasemin Schmitz

Technisches Konzept und Umsetzung:
Danadat Softwareentwicklung

1

Inhaltlich verantwortlich (gemäß §10 Absatz 3 MDStV):
Dr. Axel Jansink, Anette Sonntag

 

Professional Indemnity Insurance Information

Provinzial Rheinland Versicherung AG
Provinzialplatz 1
40591 Düsseldorf
Area covered by insurance: Worldwide

 

Register entry

Geführt bei: Amtsgericht Wuppertal
Nummer: HRB 29799

 

Regulating authority

Bezirksregierung Düsseldorf
Am Bonneshof 35
40474 Düsseldorf
Website: http://www.brd.nrw.de/

 

Regulated / Independent Professions

Legal job title: Physician

Country in which the job title was awarded: Germany

Legal job title: Pharmacist

Country in which the job title was awarded: Germany

2

Professional chamber:

Ärztekammer Nordrhein
Tersteegenstr. 9
40474 Düsseldorf
Telefon: 0211/43 02-0
Fax: 0211/43 02-1200
Mail: aerztekammer@aekno.de
Web: https://www.aekno.de/

 

Apothekerkammer Sachsen-Anhalt
Doctor-Eisenbart-Ring 2
39120 Magdeburg
Web: https://www.ak-sa.de/

 

Professional regulations:

Professional code for the North Rhine physicians, https://www.aekno.de/aerzte/berufsordnung abgerufen werden.
Professional code for pharmacists at the Saxony-Anhalt Chamber of Pharmacists, https://www.ak-sa.de/upload/Dokumente/Rechtsnormen/022_Berufsordnung abgerufen werden.

3

Social Media and other online presences

This legal disclosure also applies to the following social media presences and online profiles:
https://www.xing.com/profile/Axel_Jansink/
https://www.linkedin.com/in/axel-jansink/
https://www.xing.com/profile/Anette_Sonntag2/
https://www.linkedin.com/in/anette-sonntag-26912b63/

 

Disclaimer

Haftungsausschluss: Die Inhalte dieses Onlineangebotes wurden sorgfältig und nach unserem aktuellen Kenntnisstand erstellt, dienen jedoch nur der Information und entfalten keine rechtlich bindende Wirkung, sofern es sich nicht um gesetzlich verpflichtende Informationen (z.B. das Impressum, die Datenschutzerklärung, AGB oder verpflichtende Belehrungen von Verbrauchern) handelt. Wir behalten uns vor, die Inhalte vollständig oder teilweise zu ändern oder zu löschen, soweit vertragliche Verpflichtungen unberührt bleiben. Alle Angebote sind freibleibend und unverbindlich.

 

Links auf fremde Webseiten: Inhalte fremder Webseiten, auf die wir direkt oder indirekt verweisen, liegen außerhalb unseres Verantwortungsbereiches und machen wir uns nicht zu Eigen. Für alle Inhalte und insbesondere für Schäden, die aus der Nutzung der in den verlinkten Webseiten aufrufbaren Informationen entstehen, haftet allein der Anbieter der verlinkten Webseiten.

4

Disclaimer

Accountability for content The contents of our pages have been created with the utmost care. However, we cannot guarantee the contents' accuracy, completeness or topicality. According to statutory provisions, we are furthermore responsible for our own content on these web pages. In this matter, please note that we are not obliged to monitor the transmitted or saved information of third parties, or investigate circumstances pointing to illegal activity. Our obligations to remove or block the use of information under generally applicable laws remain unaffected by this as per §§ 8 to 10 of the Telemedia Act (TMG).

 

Accountability for links Responsibility for the content of external links (to web pages of third parties) lies solely with the operators of the linked pages. No violations were evident to us at the time of linking. Should any legal infringement become known to us, we will remove the respective link immediately.

 

Copyright
Our web pages and their contents are subject to German copyright law. Unless expressly permitted by law, every form of utilizing, reproducing or processing works subject to copyright protection on our web pages requires the prior consent of the respective owner of the rights. Individual reproductions of a work are only allowed for private use. The materials from these pages are copyrighted and any unauthorized use may violate copyright laws.

 

Graphics and Image Sources

Slider „Laptop“: ESB Professional/Shutterstock.com
Slider „Puzzle“: udra11/Shutterstock.com
„Glühbirnen“: patpitchaya/Shutterstock.com
Vita Personen-Foto: YSDesign
„Akten“: Cozine/Shutterstock.com
Bild Zwischenetappe-1: Sashkin/Shutterstock.com
Bild Zwischenetappe-2: REDPIXEL.PL/Shutterstock.com

 

Quelle: translate-24h.de

5