The Centre for Health Technology Assessment and Drug Research (CHAD) focus is on evaluation of medicines and other medicinal products for market access purposes, aiming at financing and reimbursement and pharmacovigilance .
The CHAD provides scientific information to support the decision making in healthcare policy and practice. Health Technology Assessment studies are necessary to ensure equity in the access to medicines and the most favourable benefit/risk and cost/effectiveness ratios in the drug use process. It is, therefore, of capital importance in both drug reimbursement decisions at both ambulatory and hospital settings.
The CHAD is responsible since 2008 for a Pharmacovigilance Unit of the National Pharmacovigilance System which is contracted with the National Authority of Medicines and Health Products (INFARMED, IP).
CHAD provides research services and consultancy to pharmaceutical companies within the following areas:
1. Health Technology Assessment, pricing and reimbursement (medicines and medical devices):
a. Early advice, starting at Phase I, to develop a value strategy for market access.
b. Supporting strategic value enhancements through expert panels and advisory boards.
c. Identification of unmet medical needs for modelling clinical development and economic studies.
d. Core value dossier elaboration.
e. Core value dossier adaptation for different EU marketplaces.
f. HTA, pricing and reimbursement submissions.
2. Primary research
a. Patient-based outcomes
b. Real world effectiveness studies
3. Secondary research
a. Literature searching and evaluation
b. Systematic reviews and meta-analysis
c. Indirect/mixed treatment comparisons according to methodological guidelines.
d. Comparative effectiveness studies.
e. Expert reports
4. Pharmacovigilance and Risk Management services
a. Post-marketing pharmacovigilance activities
i. EU Qualified Person for Pharmacovigilance (QPPV) and deputy
ii. Support the development and implementation of pharmacovigilance systems (Pharmacovigilance System Master File)
iii. Company core safety information (CCSI) production
iv. Preparation of written pharmacovigilance procedures (SOPs)
v. Periodic review of scientific literature
vi. MedDRA codding of suspected adverse drug reactions
vii. Electronic transmission of suspected adverse drug reactions
viii. Periodic Safety Update Reports writing and/or reviewing
ix. Support in the response to Competent Authorities information requests
x. Risk Management Plan development, review and maintenance
xi. Conducting Pharmacoepidemiology studies under Risk Management Strategies
xii. Pharmacovigilance training programs (on-the-job or at AIBILI facilities sessions)
b. Safety monitoring in Clinical Trials
i. Preparation of written pharmacovigilance procedures (SOPs)
ii. MedDRA codding of suspected adverse drug reactions
iii. Electronic transmission of suspected adverse reactions
iv. Preparation of SAE case narratives
v. Safety database services
vi. Global regulatory requirements and consulting
vii. Development Safety Update Report (DSUR)
viii. Periodic review of scientific literature in support of the DSUR
ix. Interim Safety reports (on demand)
x. Signal detection and evaluation
xi. Response to Competent Authorities information requests
xii. Ability to constitute a Data and Safety Monitoring Board to reevaluate adverse reactions
c. Risk Management strategies: since the new EU pharmacovigilance legislation came into force in 2012, it has become statutory requirement for pharmaceutical companies to produce risk management plans (RMPs) for a broad range of medicines. CHAD has the capability to conduct studies to monitor the efficacy and effectiveness of risk management measures:
i. Prescription-event monitoring studies
ii. Registry studies
iii. Analytical observational studies (case-control, cohort)
iv. Drug utilization studies
v. Safety signal management
PHARMA BIOTECH CONSULTANTS (Hamburg, NJ, USA)
Pharma Biotech Consultants focus is clinical/ regulatory/ business consulting for the Life Sciences/ Healthcare industry with strong medical and scientific content.
Pharma Biotech Consultants services include:
For more information on Pharma Biotech Consultants, please visit http://www.pharmabiotechconsultants.net