a short introduction to dada consultancy, your trusted partner in pharma support
TRANSCRIPT
1
DADA ConsultancyCompany Presentation
24 October 2016DADA Consultancy B.V.
2
• DADA Consultancy is a premier and independent consulting agency
• Our aim is to provide state-of-the-art product development, regulatory affairs, clinical and pharmacovigilance/device-vigilance services and to establish long-term partnerships with our clients.
• At DADA we have a passion for detail while maintaining focus on our client’s ultimate goal
Introduction
24 October 2016DADA Consultancy B.V.
3
• DADA was established in 1984 and is based in the Netherlands
• Human and veterinary medicinal products• Medical devices and nutraceuticals• Cosmetics and herbal medicinal products • Covering all European Member States and related
regulated markets
Introduction
24 October 2016DADA Consultancy B.V.
4
• Pharmaceutical development– API– Finished Product
• Clinical Support• Regulatory Affairs• Pharmacovigilance• Medical Devices• ADOH
– Acting as MA holder– EU batch release service
Services
24 October 2016DADA Consultancy B.V.
5
Pharmaceutical development
• Complete product development: from API to finished medicinal product – network of contract laboratories and manufacturers
• Tailor-made project management– tight cooperation with regulatory and clinical experts
ü Over 60 product development projects delivered
24 October 2016DADA Consultancy B.V.
6
Clinical support
• Extensive experience in writing clinical and non-clinical overviews
• Designing clinical programs – writing clinical trial applications – selecting the appropriate CRO – writing the required documentation– auditing clinical studies and CROs
• Scientific advice
24 October 2016DADA Consultancy B.V.
7
Regulatory Affairs
• Independent and optimal advice on the best suitable RA strategy
• Writing complete application dossiers– human and veterinary medicinal products
• Running various registration procedures in EU • Handling required variations and update submissions
ü Written and submitted over 700 state-of-the-art marketing application files
24 October 2016DADA Consultancy B.V.
8
Pharmacovigilance
• QPPV services with approved PV system • Individual case or periodic reporting of safety
information to the applicable authorities• Local contact point for patients/HCPs• Advise on or audit of PV system• Complete compliance with regulatory demands
ü Optimally monitor the benefit-risk balance of your products to safeguard your marketing authorisation.
24 October 2016DADA Consultancy B.V.
9
Medical Devices
• Upcoming New Regulations for Medical Devices and In-Vitro Diagnostics
• Revision 4 of MEDDEV 2.7/1 – Clinical Evaluation• Increased scrutiny and stricter requirements• DADA expertise used for clinical and vigilance support
is now also dedicated to medical devices
24 October 2016DADA Consultancy B.V.
10
Medical Devices
• Clinical services– Feasibility study– Advise on the need for
clinical trials– Clinical study support– Comprehensive
literature search and review
– Assessment of clinical data
24 October 2016DADA Consultancy B.V.
• Vigilance services– Pre-market and post-
market reporting of incidents
– Field Safety Corrective Actions
– Periodic summary reporting
– Post-market clinical follow-up studies
11
• Differences between countries in RA requirements despite EU guidance
• Old biostudies – ISR• Determining reasons for failed BE studies• Sterile products and unconventional sterilization
methods• Deviations and OOS
investigations, GxP CAPAs• Risk Management Plan updates
Problem solving
24 October 2016DADA Consultancy B.V.
Examples:
12
ü Successful development of > 60 new productsü Successful compilation and submissions of > 700
applicationsü Fully compliant PV system, with EU-QPPV,
PSMF/DDPSü ISO 9001 certification
Successes
24 October 2016DADA Consultancy B.V.
13
• Experienced auditors– GMP– GCP– GVP
• Performing audits
• Preparing customers for inspections
GxP
24 October 2016DADA Consultancy B.V.
14
• Contact
• Telephone: +31 24 373 03 09• Fax: +31 24 373 00 46• e-mail: [email protected]• Web: www.dada.nl
Office
24 October 2016DADA Consultancy B.V.
Godfried Bomansstraat 316543 JA NijmegenThe Netherlands
15
Icelandic Office
Hrund klínísk ráðgjöf ehf.Arna Hrund ArnardóttirSelvað 7110 Reykjaví[email protected]. 625 7787
24 October 2016DADA Consultancy B.V.
16
Polish Office
Dada PolskaEwa SzczecinskaUl. Rycerska 583-200 Starogard Gdań[email protected]
24 October 2016DADA Consultancy B.V.