This document summarizes approaches to post-marketing surveillance of biological products, with a focus on vaccines. It discusses both passive surveillance methods like the Vaccine Adverse Event Reporting System (VAERS) and active surveillance efforts like the Vaccine Safety Datalink. The document also provides examples of recent vaccine safety issues that were identified through these surveillance systems and international collaboration on vaccine safety through organizations like the World Health Organization.
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TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
TSDP tells about Post-marketing Drug-surveillance and their types. To know more about regulatory medical writing training, contact- hello@turacoz.in. know more, visit: http://turacozskilldevelopment.org/
What are some of the challenges in pharmacovigilance? This presentation offers you more information on signal detection, signal management and risk minimisation measures.
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
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What are some of the challenges in pharmacovigilance? This presentation offers you more information on signal detection, signal management and risk minimisation measures.
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
Global pharmaceutical companies manufacture and distribute a broad portfolio of drug products in multiples regions and countries. The pharmacovigilance system must ensure safety data collection in compliance with local regulations, and consolidate all sources to ensure an ongoing monitoring of potential changes in benefit-risk profiles. It must also guarantee a timely communication to patients, prescribers and regulatory authorities. The complexity resides in the need for a dense network of local safety departments, a strong global organisation processing and analysing cases, and a reporting system ensuring compliance to heterogeneous regulatory requirements. Pfizer has one of the largest pharmacovigilance department among all global companies, and has established patient safety as a core priority. We will describe how pharmacovigilance is organised at Pfizer, global compliance and individual patient safety.
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A tongue-in-cheek look at UFO data collected by the British government in 2009, demonstrating the awesome capabilities of the Palantir Government analysis platform...
The IB Geography syllabus specifies several skills that should be mastered during the course. The skills are not assessed explicitly in external exams but they are assessed implicitly via data response questions and the expectations of quality essays. The internal assessment based on geographic fieldwork and geography extended essays are the main ways that students have opportunity to demonstrate their geographic skills.
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https://sites.google.com/site/frontierslearningseries2016/
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Using Data Mining Techniques to Analyze Crime PatternZakaria Zubi
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A vaccine is a biological preparation that improves immunity to a particular Disease.
No vaccine is completely safe or completely effective, while all known vaccine adverse events are minor and self limited, some vaccine have been associated with rare but serious health effects.
FDA guidance for post marketing study commitments - Pharmaceuticals
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Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
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ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
PHARMACOVIGILANCE_SLIDE. Insight to pharmacovigilance, covering basics and va...ssharmapharmacy005
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Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
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of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
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Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
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RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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1. 1
Post-Marketing Surveillance:
Passive and Active Approaches
and Use of Electronic Databases
Karen Midthun, MD, Deputy Director
Center for Biologics Evaluation and Research, FDA
ICDRA Pre-Conference
Berne, Switzerland
September 15, 2008
2. 2
Topics for today
• Approaches, needs, and opportunities to
further enhance safety of vaccines and
other biological products, with focus on
post-marketing surveillance systems
• Importance of international collaborations
• Articulating a vision of an enhanced safety
system
3. 3
Vision for CBER
INNOVATIVE TECHNOLOGY ADVANCING
PUBLIC HEALTH
• Protect and improve public and individual
health in the US and, where feasible, globally
• Facilitate the development, approval and
access to safe and effective products and
promising new technologies
• Strengthen CBER as a preeminent
regulatory organization for biologics
4. 4
Biological Products Regulated by CBER
• Vaccines (preventive and therapeutic)
• Blood, blood components and derivatives
• Allergenics
• Cell and Gene Therapies
• Tissues
• Xenotransplantation Products
• Related Devices (including certain IVDs)
5. 5
Major CBER Initiatives
• Pandemic influenza and emerging threat
preparedness
• Enhancing product safety
- Integrated safety teams and use of informatics
• Manufacturing and product quality activities
• Critical path
• Global collaboration
6. 6
Enhancing Product Safety
• Multi-disciplinary safety teams for vaccines, blood, and
tissues (epidemiologists, clinical/product reviewers,
compliance/manufacturing experts, communications) to
improve acquisition, analysis, and communication of
safety information
– Encompasses entire product life cycle and all data
relevant to safety, manufacturing, and compliance
– Uses data to evaluate emerging safety issues
– Coordinates FDA response to emerging safety issues
with other HHS agencies (CDC, NVPO, NIH), industry
– Enhances collaboration with other govt. agencies,
WHO, and other entities on safety initiatives
– Proactive: develop research, policy, outreach agenda
7. 7
Assuring Product Safety
• Pre-licensure
– Evaluate clinical, nonclinical, product, and
manufacturing data, including facility inspection
– Pharmacovigilance plan evaluated as part of
biologics license application and informs post-
marketing surveillance and studies
• Post-licensure
– Lot release
– Biennial inspections
– Evaluation of post-marketing adverse event
reports (VAERS for vaccines and AERS for other
products) and studies
8. 8
Pharmacovigilance Plan (ICH E2E)
• Basis for design of Phase 4 studies, passive
surveillance and other components of
pharmacovigilance plan is through analysis
of Safety Specifications:
– Important identified risks
– Important potential risks
– Important missing information
• Manufacturer should consider actions to
address any such concerns
9. 9
Pharmacovigilance Plan (cont)
• Staff member from the Division of Epidemiology is
assigned to the Biologics License Application
(BLA) review team
• Primary responsibility for review of
pharmacovigilance plan and agreement with
manufacturer regarding post-marketing safety
studies is with Division of Epidemiology, working
together with rest of multi-disciplinary review team
• As appropriate, pharmacovigilance plan is
presented to FDA Advisory Committee, together
with efficacy and safety data from BLA prior to
licensure
10. 10
Why do we need post-marketing
surveillance?
• Rare adverse events may not be detected in pre-
licensure studies
• Why? Because even very large clinical trials have
limitations. For example, to detect a doubling in an
adverse event that occurs at a rate of 1/1000 would
require a sample size of 50,000 (two-arm,
power=80%, alpha=5%)
• The post-marketing surveillance activities
described in the slides that follow focus on
vaccines, but the same principles are applicable to
other medical products
11. 11
Post-Marketing Surveillance for
Vaccines: Passive Approach
• Vaccine Adverse Event Reporting System (VAERS)
– National system for passive surveillance of
adverse events after vaccination established in
1990 in response to the National Childhood
Vaccine Injury Act of 1986
– Jointly managed by FDA and CDC
• VAERS contractor receives reports, manages
report database, and conducts routine report
follow-up
– Reports received from health professionals,
vaccine manufacturers, and the public
12. 12
Adverse Event Report Review
• Manufacturer “15 day reports” of serious
unexpected events and direct reports of death and
serious adverse events are forwarded by VAERS
contractor to assigned CBER staff within 1
business day
• Reviewed daily for unexpected events
• Follow-up with reporters as necessary
• Periodic reports/periodic safety update reports
reviewed when submitted
• Weekly vaccine safety surveillance meeting
13. 13
VAERS: Advantages
• National in scope, covers diverse
populations
• Able to detect rare adverse events
• Rapid detection of possible signals
(hypothesis generating)
• Can assess adverse events by lot
14. 14
VAERS: Limitations
• Reported diagnoses not verified
• Lack of consistent diagnostic criteria
• Wide range of data quality
• Underreporting
• Inadequate denominator data (i.e., number of
persons vaccinated)
• No unvaccinated control group
• No information on background rates of conditions
in general population
• Usually not possible to assess whether vaccine
caused the reported adverse event
15. 15
Post-Marketing Surveillance for
Vaccines: Active Approaches
• Manufacturers’ phase 4 studies
• FDA sentinel initiative
– Activities ongoing or under development with Centers
for Medicare and Medicaid Services, Department of
Veterans Affairs, Department of Defense large medical
encounter and claims databases for controlled
observational studies of specific safety issues
– Other public-private partnerships being sought
– FDA Amendments Act of 2007 prescribes an active post-
market risk identification and analysis system intended
to link and analyze safety data from multiple sources,
with goal of including 25M patients by 2010 and 100M
patients by 2012
16. 16
Post-Marketing Surveillance for
Vaccines: Active Approaches
• CDC’s Vaccine Safety Datalink (VSD)
– 8 geographically diverse health maintenance
organizations that participate in large linked
database that tracks
• Vaccination (exposure)
• Outpatient, emergency department, hospital
and laboratory data (health outcomes)
• Demographic variables (confounders)
– Includes approximately 3% of U.S. population
– “Hypothesis testing” studies can be conducted
17. 17
VSD Analyses: Advantages
• All medical encounters are available at most
sites
• Allows calculation of background rates of
various conditions of interest
• Medical chart review is accessible
• Available for urgent studies
18. 18
VSD Analyses: Limitations
• Sample size may be inadequate for very rare
adverse events (e.g., Guillain-Barre
syndrome with incidence rate of 1-2/100,000
per year)
• Lack of demographic and socioeconomic
diversity in HMO practices
• Variable accuracy of coded data used for
studies
• Unvaccinated population may be small
19. 19
FDA and CDC Interactions on
Vaccine Safety
• FDA and CDC, in conjunction with HHS and
other agencies, work closely together on
vaccine safety surveillance activities (e.g.,
VAERS, VSD and other active surveillance
activities) and the analysis and
communication of safety concerns
20. 20
A Case Study: Rotavirus Vaccine
and Intussusception (IS)
• First rotavirus vaccine (Rotashield) licensed
by FDA in August 1998
– Pre-licensure: IS noted as possible AE,
difference in rate between vaccine and placebo
groups not statistically significant
– Post-licensure: likely excess of IS noted in
VAERS, CDC-conducted epidemiological studies
show elevated risk, and in October 1999, ACIP
withdraws recommendation for vaccine and
manufacturer voluntarily withdraws vaccine from
market
21. 21
How did this impact next rotavirus vaccine?
• Second rotavirus vaccine (Rotateq) licensed by
FDA in February 2006
– Pre-licensure: very large safety study (70,000
infants, 1:1 vaccine to placebo), no increased
risk of IS
– Post-licensure surveillance: VAERS,
manufacturer’s phase 4 study (44,000 infants)
and CDC’s VSD study (90,000 infants)
– To date, no signal of increased risk of IS after
Rotateq (Pediatrics 2008;121:1206-1212)
– Updates communicated through changes to
labeling and patient information, Public Health
Notification, MMWR publication
22. 22
Other Recent Examples of Vaccine Safety
Issues
• Possible increased risk of Guillain-Barre syndrome
after Menactra (quadrivalent meningococcal
conjugate vaccine)
– http://www.fda.gov/cber/safety/gbs102006.htm
• Possible increased risk of febrile seizures after
Proquad (combined Measles, Mumps, Rubella and
Varicella Vaccine)
– http://www.fda.gov/cber/label/proquadLBinfo.htm
• Update on the safety of Gardasil (human
papillomavirus vaccine)
– http://www.fda.gov/cber/safety/gardasil071408.htm
23. 23
Global Collaboration
• CBER is a WHO Collaborating Center
– Expert Committee on Biologic Standards
– Strategic Advisory Group of Experts
– Global Advisory Committee on Vaccine Safety
– Global Collaboration on Blood Safety and Blood Regulators
Network
– Expert consultation in specific product areas
– Participates in WHO prequalified vaccines program
– Participates in WHO teams to assess competency of national
regulatory authorities (NRA) around the world
– Training: Works with WHO Developing Countries Vaccine
Regulators Network to help build global regulatory capacity of
NRAs with regard to vaccines
24. 24
Global Collaboration
• Information sharing arrangements and engagement
in priority areas with various regulatory authorities
and WHO
• Brighton collaboration for standardized case
definitions of adverse events following immunization
• CIOMS vaccine safety working group
• Partnering with WHO and NGOs to explore additional
means of providing global regulatory assistance and
capacity building
• International Conference on Harmonisation
• Pharmaceutical Inspection Cooperation/Scheme
25. 25
FDA Amendments Act (2007):
Some Highlights
• Pediatric Research Equity Act: Pediatric studies
required with application or supplement for new
active ingredient, indication, dosage form, dosing
regimen, or route of administration, unless deferral
or waiver granted
• Safety: FDA to require post-marketing studies or
clinical trials at time of approval, or after approval,
based on certain safety concerns (e.g., to assess
known serious risk or signal of serious risk, or to
identify expected serious risk if data indicate such
potential)
26. 26
FDA Amendments Act (cont)
• Safety Labeling Changes: FDA to require if new
safety information needs to be included, specific
timelines noted
• Risk Evaluation and Mitigation Strategies: FDA
can require at time of or after approval, if
deemed necessary to ensure that benefits
outweigh risks
• Active Post-market Risk Identification and
Analysis System: to link and analyze safety
data from multiple sources, with goal of
including
– at least 25M patients by 2010,
– at least 100M patients by 2012
27. 27
Vision for Post-Market Surveillance
• All patients’ vaccinations and health outcomes
are immediately and continuously accessible in
automated database(s) allowing optimal
detection and analysis of potential problems in
vaccine safety
– Not there yet – both major limitations and
opportunities in current health information
systems
– Both problems and solutions to enhance
vaccine safety information and analysis are
applicable to safety initiatives for other
medical products
28. 28
Post-Market Surveillance: Needs
• Access to more patients and better data
– Given diversity of data sources, innovative
approaches to retrieval of key data may have
great potential vs. single unified system
– Better background rates, comparable “control”
populations
– More consistent event/disease nomenclature, IT
architecture, data interchangeability, quality
– Increase in “non-medical” data sources – e.g.,
pharmacy, supermarket, employer vaccination
29. 29
Post-Market Surveillance:
Opportunities
• Access to additional health systems data: CMS,
VA, DoD, managed care organizations
• Access to global data: regulatory, inspectional,
health systems, international surveillance and
pharmacovigilance
• Better analytic tools and methods
30. 30
Communications and Transparency
• Early and continuing communication of possible
safety signals is expected and beneficial to
consumers, health care providers, science
– Critical to confidence in integrity of vaccine safety
system, government and industry
– Enhances reporting and informs decision-making of
consumers and health care providers
– Initial information and medical/scientific opinion and
assessments often evolve
– Conveying uncertainty of risk difficult, includes
potential for decreased use of safe and effective
products
31. 31
Summary
• Pre-licensure clinical, product, and
manufacturing data are critical foundations for
evaluating the safety and effectiveness
• However, post-licensure surveillance is
essential to assure product safety
• Vaccines and other medical products have risks
that may include rare serious adverse events
not detected in pre-licensure studies
• Government agencies play an important role in
monitoring, analyzing, and communicating re
safety of vaccines and other medical products
32. 32
Summary (cont)
• Passive and active surveillance, including
observational studies, after licensure are needed to
detect and evaluate vaccine safety concerns
• Need for robust, continuously operating and
technologically advanced safety monitoring
systems that include epidemiological, clinical, and
laboratory assessments of causality
• Public communication and engagement regarding
vaccine safety concerns is critical to maintaining
confidence in the vaccine safety system, optimal
vaccine coverage, and the public health
33. 33
Acknowledgments
• Robert Ball, MD, MPH, ScM
• Jesse Goodman, MD, MPH
• John Iskander, MD, MPH
• Douglas Pratt, MD, MPH
• Joan Blair, MA
34. 34
Thank you!
• We are actively engaged in assuring the safety,
effectiveness, and availability of products that
touch so many lives and are critical for public
health and preparedness
• Emerging threats, technologies, and opportunities
demand constant renewal of scientific expertise
and capacity
• The challenges and opportunities for leadership
and public health are truly global – and
collaboration is key!
CBER: INNOVATIVE TECHNOLOGY ADVANCING
PUBLIC HEALTH