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IN2Pharma's Company Presentation

IN2Pharma - Consulting in Pharma & Healthcare
by

Caroline Steensels

on 25 September 2017

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Transcript of IN2Pharma's Company Presentation



Professors at Belgian Universities
Lobbyers
Pharmaceutical Professionals in other EU countries
Medical Writers
Medical Training & Writing
Pharmacovigilance activities
Advertising & Promotion
Scientific training for marketing, sales & other teams
Development
Scientific coaching
Regulatory & Juridical awareness training

Medical writing
Expert reports
Publications (professional & public literature)
Q & A support / call center

Optimization pharmacovigilance system

Ensuring PV compliance:
SOP management
Training personnel
Reporting of adverse drug reactions
24/7 permanence
PSUR Management & Writing
Contact with authorities

Set-up & maintenance QA system:
practical, juridical & regulatory

Adherence study
Customer satisfaction
Impact of accessibility
Safety & efficacy
Collection of benefit-risk data


Unique Experience !
First multicenter pharmacy study in Belgium
Randomised, double blind, placebo-controlled, comparative, multicenter GCP study
Study sites: 35 public pharmacies
Requested & approved by FAMHP
Study product = OTC drug

Results:
Inclusion of 453 subjects
Efficacy & Safety have been proven
Development of a feasible setting for clinical research in public pharmacies

References

Hof ter Loonst
Terloonststraat 22
B-1910 Kampenhout
Medical Training
Creation of training material
Face to face scientific coaching
Regulatory & Juridical awareness

Pharmacovigilance
Expert reports
Protocols
Publications
Offices
Your one-stop-shop solution
in Pharma & Healthcare
Your ONE-STOP SHOP SOLUTION!
WANT TO DISCOVER IN2PHARMA ?
Medical Writing
Medical support
PV permanence
24/7 Permanence
Truthful but commercially strong advertising

Advice, second opinion or delivery of a QP

Qualified Person A&P - RD 7 april 1995
Advertising & Promotion
- SOPs, QATAs, licenses, training, batch release -
GMP: MIA application, GMP SOPs,
release for European market
Selection
of projects
Potential of this concept ?
PV training
Local Contact Person
MA safety sections & HA questions
PV Quality system: SOPs, gap analysis, CAPA
Daily business:
administrative batch release, receipt & handling of PQCs, returned goods, Q&A, etc.

Qualified Person GMP
EU QPPV
Experts in Market Access, qualification and validation of computerized systems, lab equipment, analytical methods
Healthcare compliance
Article 10 - Mdeon
Compliance check Gifts & Benefits
Transparency
Disclosure of Transfers of Value
What do
we offer?
Founded by Caroline Steensels in 2005
Today an organization of 9
Business Center facilities
GDP: Create a complete Quality Management System around
the legal construction
We can act as your QP/RP
Full transcript