DADA Consultancy BV (DADA)

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www.dada.nl
DADA Consultancy BV (DADA)
Type Public / Private

DADA Consultancy BV (DADA) is a premier and independent consulting agency. DADA has established its sound reputation as a highly specialized, reliable partner of international pharmaceutical companies. We offer a full range of tailor-made developmental and international regulatory affairs and pharmacovigilance services in the fields of human and veterinary medicinal products, nutraceuticals, herbal medicinal products, medical devices and cosmetics, covering all European Member States and related regulated markets.

The DADA-team consists of dedicated and highly trained professionals in the pharmaceutical and biomedical field who are supported by a network of external experts, whenever necessary. In this way, DADA is able to provide the best possible services and to find solutions for your challenges.

Their aim is to provide state-of-the-art regulatory affairs and pharmacovigilance services and to establish long-term partnerships with our clients. They have standing partnerships with over 50 international pharmaceutical companies, both human and veterinary. For some of these companies DADA acts as their “virtual private” regulatory affairs or pharmacovigilance department, looking after all required activities. 

At DADA they have a passion for detail while maintaining focus on our client’s ultimate goal. We often solve uncommon problems with uncommon approaches, unlocking your data’s full potential.

DADA Consultancy has recently obtained ISO 9001:2015 certification.

referencehttp://www.dada.nl/

History

DADA Consultancy BV (DADA) is a Dutch independent agency specialized in supporting international pharmaceutical companies. This company is present on the market for over 30 years and in this period DADA has reached recognized prestige within the international pharmaceutical industry based on the quality of their work.


Services

DADA offers companies a full range of services also in the field of pharmaceutical development, quality control, quality assurance, and clinical and pharmacovigilance support. They are experts in international regulatory and regulatory services and customized pharmacovigilance services in the fields of human and veterinary medicines, nutraceuticals, herbal medicines, medical devices and cosmetics, covering the European markets and related regulated markets.

EU Qualified Person for Pharmacovigilance (QPPV)

Within the EU, each Marketing Authorisation Holder of human, veterinary or herbal medicinal products should ensure to have at his disposal a single point of contact, with a deputy, who is available 24/7 to act as the Qualified Person for Pharmacovigilance (QPPV). The QPPV has the following prime responsibilities: 

Description of the Pharmacovigilance System in the PV System Master File (PSMF)

EU Directive 2001/83/EC requires that every Marketing Authorisation Application should include a summary of the Pharmacovigilance System Master File being employed by the pharmaceutical company that filed the application. This summary is intended to provide proof that there is a Qualified Person for Pharmacovigilance at his disposal and that this QPPV is available. For applications submitted after 2 July 2012, a Risk Management Plan should also be submitted. Finally, the PSMF is intended to provide the competent authorities with proof that the applicant as a (future) Marketing Authorisation Holder is capable to deal with adverse events properly, including collecting and notifying the competent authorities. 

Safety reports processing from clinical trials and post-marketing sources

DADA is capable of receiving safety data on your behalf from the public, from health professionals, competent authorities, clinical trials and literature sources, amongst others. The experienced team at DADA will conduct triage of case reports to determine seriousness, enter the data into our pharmacovigilance database, code the medical information according to standardised MedDRA terminology and provide medical review and ongoing surveillance of case reports.

Local (QP)PV support Adverse Events/Medical Information/Product Complaints processing

DADA can provide you with local support staff to receive and process medical inquiries, adverse event reports (see our section on safety reports processing) and product complaints and forward these to the applicable departments within your company. We offer experienced staff to take on the role of local QPPV in those countries where this is required. Through our network of experienced consultants, we can offer this service throughout the EEA.

Expedited reporting of case reports to Competent Authorities, EudraVigilance, FDA, Ethics Committees, Institutional Review Boards and Investigators

One of the most common causes of critical findings in Pharmacovigilance Inspections is non-compliance with the expedited reporting (15 day) of spontaneous serious adverse drug reactions. DADA has a quality system implemented to ensure that expedited reports are reported in time to competent authorities. Reports may be submitted electronically or by hard copy as required by local regulations. DADA is registered with EudraVigilance to facilitate electronic reporting. EMA-trained staff ensure compliance with the rigorous requirements of such a system. For medical devices, we can ensure timely incident reporting per applicable guidelines.

XEVMPD population and maintenance

DADA is capable of processing the regulatory information contained in the Summary of Products Characteristics and submitting this information to the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) in line with Article 57(2) of the new pharmacovigilance legislation. The experienced team at DADA will conduct several quality checks during the creation of product report messages (XEVPRM) for submission to the XEVMPD and keep you informed of successful population. Maintenance of the XEVMPD will require close and clear communication to ensure timely updating of the submitted information, a trademark of the DADA team.

Periodic reporting, through Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Addenda to the Clinical Overview, and Annual Safety Reports (ASRs)/Developmental Safety Update Reports (DSURs)

The major goal of pharmacovigilance is to ensure continuous monitoring of the safety profile of medicinal products. To verify that MAHs live up to these obligations, competent authorities require the submission of periodic safety reports wherein an overview of the safety findings is presented. For products in clinical trials, FDA requires submission of Investigational New Drug (IND) reports, whereas EMA requests annual Developmental Safety Update Reports (DSURs) and other regions may require Annual Safety Reports (ASRs). For products that have received marketing authorisation, Periodic Safety Update Reports (PSURs) are required, also referred to as Periodic Benefit Risk Evaluation Reports (PBRERs). As specified in the Good Vigilance Practices, the periodicity of these reports may be different depending on the age of the product, from 6 month-intervals to three years or more for generic products. Addenda to the Clinical Overview (AddCO) are generally submitted during a renewal, to present the competent authorities with a short overview of the information presented in the PSURs submitted during the marketing authorisation period including the period not yet covered by a PSUR.

Global and local literature screening and review

The MAH is required to regularly screen the published medical and scientific literature, to ensure that any mention of their products is duly noted and reported to competent authorities. DADA pharmacovigilance staff is experienced in carrying out this activity on your behalf and can comprehensively manage your literature screening requirements in a cost-effective manner in conjunction with writing periodic safety reports and signal evaluation documents for your products. Our weekly search is not only limited to identification of individual case safety reports, but also includes detection of potential safety issues. Per your requirements, we can also conduct local literature screening in our territories. In addition, we carry out ad hoc literature searches for purposes of signal evaluation or for identifying safety concerns for inclusion in PSURs.

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