Risk Management and Pharmacovigilance

 

Risk Management and Pharmacovigilance

Annette Stemhagen, DrPH, FISPE, provides an insider's view on Real-World Evidence and other hot topics discussed at the DIA 2017 Annual Meeting.

As our industry shifts importance from volume to value, it is more important than ever to have a strategic approach to collecting and analyzing evidence. UBC offers a robust history of building economic evidence to demonstrate and support the value of products on behalf of...

Second-generation anti-psychotic medication use has increased dramatically, although the prevalence of the indicated psychiatric conditions (bipolar, schizophrenia) has remained stable The potential harm from off-label prescribing for mild conditions that have little evidence...
Treatment satisfaction is an important predictor of real-world medication adherence in chronic medical conditions such as asthma and COPD. The objective of this study was to identify and describe measures used to assess treatment satisfaction and preference in patients with...
In the absence of secondary sources of health care data, chart review studies are necessary to fulfill peri- and post-approval evidence gaps such as informing on patient profiles, treatment effectiveness, and clinical and safety outcomes. Multinational studies (conducted in more...
This study aimed to evaluate whether use of long-acting bronchodilators increases the risk of acute myocardial infarction (MI) in patients with COPD who are at high risk for cardiovascular disease.
To summarise and highlight what the EU Orphan Drug Regulation has accomplished since its inception.
Healthcare needs a hero | UBC
Biotech and pharmaceutical professionals typically don't get much recognition. That needs to change. It's time to shine a light on the heroes who walk among us, those who discover, develop and deliver life-saving medicine.
Cost-containment in health care paired with global regulatory approvals of biosimilar agents pave the way for less expensive alternatives to complex biologics. Regulators and payers increasingly demand robust safety and effectiveness data in real-world settings. Our objective...
Limited evidence exists regarding the risks and benefits of antipsychotic (AP) polypharmacy, however, antipsychotic polypharmacy is not uncommon and is compounded by widespread off-label prescribing. This study uses repeatable methods and real world data to profile AP users and...
When existing secondary data cannot address multiple stakeholder needs, primary data collection (retrospective and/or prospective) should be considered in combination to or as a standalone study design. Our objective was to explore the strengths of hybrid studies that combine...
Databases are essential tools for pharmacoeconomic research. North America has large administrative claims, hospital, and electronic medical record (EMR) databases. Databases in Europe are scarcer, integrated primary and secondary care data are rare, and claims with...
In August 2015, the US Food and Drug Administration (FDA) released a draft document to address some challenges in developing drugs for rare diseases. The following practical suggestions can be drawn from the FDA guidance.
To describe the psychosocial impact of facial aging in adult females and males.
In 2014, omacetaxine mepesuccinate became the first cytotoxic chemotherapy approved for subcutaneous injection by patients/caregivers at home. The FDA issued a post-market requirement (PMR) to identify associated risks using failure modes and effect analysis (FMEA). FMEA is a...
Observational Studies and Registries | UBC
UBC offers strategic, scientifically rigorous studies designed to address stakeholder-driven evidence requirements. UBC is an industry leader in the design and global implementation of observational cohort studies, registries, large streamlined studies, other observational...

Generating real-world evidence is essential to uncovering the potential effects a product may have on pregnancy outcomes, particularly for women of childbearing age who require chronic therapy for diabetes, depression, epilepsy, asthma and more.

Understanding key...

Designed especially for drug safety scientists and epidemiologists, the software’s analytical modules assist in clinical evaluation of at-risk and signal interpretation, allowing sponsors to rapidly respond to regulatory inquiries regarding health outcomes in the context of real...
Few studies have estimated time and associated cost related to a paediatric vaccination visit. Time and Motion (T&M) methodology is suitable to collect efficiency-related outcomes.The aim was to quantify active healthcare professional (HCP) time and associated costs of a...
In patients with bone metastases from solid tumours, denosumab (Dmab) subcutaneous (SC) injection represents an alternative formulation to zoledronic acid (Zol) intravenous (IV) infusion and a superior efficacy for skeletal-related events prevention. This observational Time and...
Since 2011, denosumab (Dmab) subcutaneous (SC) injection is available as a superior treatment option in patients with bone metastases from solid tumours, compared with zoledronic acid (Zol) administered as an intravenous (IV) infusion. Although Zol was the mainstay treatment for...
For both prospective and retrospective observational study designs, data collection errors and missing data are inherent challenges. Our purpose was to outline principal challenges for either methodology and propose solutions aiming to increase overall quality of study data and...
The objective of this study was to compare the one-year costs related to cardiac adverse events post-index procedure discharge of Absorb and Xience.
Dexmedetomidine was approved for ICU sedation in adults in the EU in 2011, but has been available in other countries since 1999 and used in many different clinical situations including in children. This study evaluated off-label use of dexmedetomidine in usual care in the EU.
Infographic: Rare Disease Patients Have Many Questions
Do you have the right answers for patients with rare diseases? UBC can help with our comprehensive services.
PASS brochure | UBC
UBC is an industry leader in designing and conducting post-authorisation safety studies (PASS) in Europe. Our staff combines deep scientific knowledge with industry and regulatory experience to design PASS protocols for both mandated and non-mandated PASS.
This study utilizes 2 data sources: (1) retrospective patient medical chart review of demographics, including safety and tolerability of prolonged treatment with gefitinib as part of the ICAP; and (2) retrospective review of serious adverse event (SAE) reports in the AstraZeneca...
CLÆRITY can be used to tap publicly available data sources such as FAERS and Vigibase as well as a manufacturer’s internal adverse event data to provide a holistic solution for safety surveillance and signal detection. It also can be customized to a client’s workflow and process...
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. Long-acting bronchodilators (LABs) are the mainstay of pharmacological maintenance therapy for COPD. However, the possibility that use of LABs may lead to risk of...
Increasingly, real-world observational DUS are being conducted as part of the marketing authorization process or post-market approval to assess risk management activities, off-label drug use, safety and effectiveness. Determine the best approach for conducting observational DUS...
Large, diverse U.S. and European healthcare data sources are increasingly popular, enabling an evidence-based approach to research, development, drug safety, and commercial strategy. However, healthcare data sources are inconsistent in content and format, making them difficult...
This forum will discuss different approaches to postmarketing safety data collection for products used during pregnancy and explore innovative methodologies to increase the safety information for products used in pregnant women.
Pharmacovigilance questions you were afraid to ask UBC
From the time humans begin taking an investigational new drug, pharmacovigilance measures play a critical role in every phase of a product’s lifecycle. However, understanding pharmacovigilance requirements can be daunting even for seasoned industry pros. This overview will...
CEWorks allows users to explore patterns of healthcare use and the associated costs in a user-defined cohort. Results provide information on the healthcare experience for a study population in defined timeframes. Healthcare researchers can rapidly query large, complex...
To understand the cost range for pediatric vaccine administration across different countries and to describe the costing methodologies employed for its calculation.
With oral antineoplastic agents (OAAs) becoming the mainstay of treatment for several cancer types, understanding risk factors for medication non-adherence is becoming increasingly important in oncology. Patient-reported outcome (PRO) instruments may provide valuable insight on...
Medication Guides are patient-directed, Food and Drug Administration (FDA)-approved labeling intended to provide risk and safe-use information for prescription medications in easy-to-read, lay language. They were introduced to help patients understand and manage risks and...
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. Long-acting bronchodilators (LABs) are the mainstay of pharmacological maintenance therapy for COPD. However, the possibility that use of LABs may lead to risk of...
Market Research for Clinical and Commercial Programs
UBC delivers global solutions to patient recruitment challenges faced by pharmaceutical, government, and biotech sponsors. Among the services we provide are qualitative research with various stakeholder groups — healthcare providers, specialists, pharmacists, patients, and...
UBC is a leading provider of Risk Management services. Our experts have designed, implemented and evaluated more than 100 RiskMap and REMS programs, giving them a firm understanding of FDA and EMA requirements and the similarities and differences between the two. We consult with...
We offer customised consulting, development and implementation solutions in clinical development and late stage research. This includes experts on the ground in the EU who can assist with clinical trials, peri & postapproval studies and value demonstration programmes. Our...
In the EU, new medications must be scrutinised by the EMA's centralised application review process before gaining approval – so accompanying safety and regulatory documentation must be properly prepared and consistent to ensure it passes the test.
Providing precise data capture and management as well as comprehensive statistical analysis of all phases of clinical research, REMS requirements, and outcomes and registries studies UBC’s Data Management and Biostatistics services bring together technology and therapeutic...

Sponsors today are challenged to properly evaluate the effectiveness of their risk minimisation activities in Europe. European Directive 2001/83/EC requires that the market authorisation holder shall “monitor the outcome of risk minimisation measures which are contained in...

Risk Management and REMS
Maximize product performance by managing risk before, during, and after launch with the industry’s most comprehensive and global suite of solutions available.
Pharmacovigilance
UBC provides technology and services that encompass safety/pharmacovigilance, risk management, signal detection, and assessment – as a comprehensive integrated program, or as stand-alone, targeted solutions.
Database Analytics Automation | DAA | UBC
Proactively manage risks and uncertainties in signal detection, strengthening, and refinement.
Every journey is unique. Choose your guide wisely. UBC offers global product safety, brand loyalty and patient access strategies that span the full product lifecycle.
Achieve and maintain market authorisation in Europe. UBC offers customised consulting, development and implementation solutions.
The market shift from oral solid to specialty medications comes with two notable dynamics impacting manufacturers. First, it is increasingly important to provide patient and physician support services, such as reimbursement and patient assistance programs. Second, the FDA has...
While some procedures and guidelines exist for company sponsored web sites, the strength of the pharmacovigilance data getting available from the non-sponsored sites is growing and hence there is a growing need to develop strong and much clearer guidelines to monitor the...
All Marketing Authorisation Holders are required by regulation to demonstrate a systematic and documented approach to signal management, the output of which should be appropriately reflected in the benefit-risk assessment of the product. The signal management process can be...
Learning Objective: Creatively evaluate the effectiveness of certain types of REMS programs using existing tools and technologies
UBC offers big solutions for small patient populations. From clinical trials to high-touch adherence programs, we know that individualized patient care is important to patients with rare diseases.
Revolution within the health regulatory bodies since the disaster of the thalidomide related birth defects during 1961 has lead the pharmaceutical companies to develop sophisticated measures to monitor the safe use of marketed products. Regulatory requirements have also changed...
Objective: To develop a model of signal management which can be adaptable to all stakeholders with different products portfolio, biotech products, products in development, recently introduced products and established products, taking into account the company resources and...
Novel multiple myeloma (MM) therapies have increased patient longevity but are often associated with notable symptom burden. This study quantified the effect of general symptom level, specific symptoms, and treatment-related adverse events (AEs) on MM patients’ health-related...
The strategic uncertainty confronting big Pharma today has put a premium on generating new ideas from outside sources – it’s the fresh wind that lifts the sails. CROs and other biopharma vendors with a business mission to guide the industry through an era of rapid change are...

Pharmaceutical manufacturers are accustomed to establishing robust procedures and systems to support compliance with the pharmacovigilance regulations set forth by regulatory bodies around the globe.  Pharmacies on the other hand have traditionally followed local state...

UBC provides an overview of the new European Union pharmacovigilance legislation and how it affects the pharmaceutical industry. PharmaPhorum, October 2013.
The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include...
Risk management plans and risk minimization plans as well as postapproval commitment studies are based on risks identified pre-approval that need to be further characterized or minimized in the postmarketing environment. Although the implementation of these activities are...

If there are no “one size fits all” risk management strategies in the EU, how are manufacturers successfully navigating multiple regulatory agencies and healthcare systems to implement programs across the continent?   Janine Collins, M.D., Senior Director, European...