The EU MDR Deadline … Are We Really Ready?EMMAIntl
With the mounting tensions that the new EU MDR has put on medical device manufacturers, the ripple effects can be seen in every department at those medical device companies...
Next Generation Compliance: Using Analytics to Reduce Compliance Riskqordata
In this SlideShare, we will cover a compliance officer’s perspective on using analytics to enhance existing compliance and monitoring programs.You will also get a hands-on walk-through of top three methods that compliance officers can use to effectively monitor spend programs and reduce spend submission risks throughout the year.
The EU MDR Deadline … Are We Really Ready?EMMAIntl
With the mounting tensions that the new EU MDR has put on medical device manufacturers, the ripple effects can be seen in every department at those medical device companies...
Next Generation Compliance: Using Analytics to Reduce Compliance Riskqordata
In this SlideShare, we will cover a compliance officer’s perspective on using analytics to enhance existing compliance and monitoring programs.You will also get a hands-on walk-through of top three methods that compliance officers can use to effectively monitor spend programs and reduce spend submission risks throughout the year.
What does the EU Non-Financial Reporting Directive mean for you?FrameworkESG
The European Union recently adopted a directive that will mandate sustainability reporting starting in 2017. Under the new law, a company must report on environmental impacts, social matters, human rights, anti-corruption, and diversity if it meets certain size or classification requirements.
This infographic was originally published at:
http://framework-llc.com/eu-mandates-esg-disclosures/
To find out how your company may need to adapt with increased regulation, contact us: info@framework-llc.com.
On June 21st, PwC’s Health Research Institute (HRI) released its annual Medical Cost Trend: Behind the Numbers 2017 report. PwC’s HRI anticipates a 6.5% growth rate for 2017—the same as was projected for 2016. The report identifies the key inflators and deflators as well as historical context to better understand the medical cost trend for 2017. Increases in the trend due to utilization of convenient care access points and an uptick in behavioral healthcare benefits for employees are being offset by more aggressive strategies by pharmacy benefit
State of Business Networks in Process Industries 2014 - Summary ChartsLora Cecere
Executive Summary
Today, the performance of an organization hinges more than ever on the effectiveness of flows between, and amongst, trading partners. It is not easy. The supply chain is not linear, and the relationships extend across geographic borders and industry sectors.
Outsourcing relationships have grown in the last decade; however, the automation of these networks has not kept pace. In the words of one respondent interviewed for this report in a facilitated workshop to review the data, “Today, we connect trading partners through spreadsheets, email, phone and fax. It is antiquated. I liken it to baling wire, chewing gum and duct tape. I need solutions that can synchronize and harmonize data across trading partners in real-time. My operating committee does not think that it is sexy to invest in B2B solutions, but it is needed. Today, it is almost impossible for us to understand the manufacturing status of purchase orders, and have accurate information readily on supply chain visibility of in-transit shipments. As a result, we make the wrong decisions, and have unnecessary wait times to get information.”
These comments echo the findings in this study. Respondents operate value networks, but they struggle to get to the data they need. The outsourcing of logistics is greater than manufacturing. Eighty-one percent of companies outsource logistics. The volume of outsourced logistics is 48% on average. In contrast, 66% of companies outsource manufacturing. The outsourced volume manufacturing volume varies, but averages 15%.
While the networks are complex, and the goals are many, progress is hard to track. This leads many supply chain leaders to ask, “What is the current state? What is the opportunity?” Answering these questions is the goal of this report.
Let’s start with the current state. As seen in Figure 2, the average respondent in this report believes that the supply chain today is more controlled and global than compared to two years ago. While they have made improvements in agility and proactivity, there is much more left to do. The largest challenges are in the use of outside-in data to improve channel sensing and reduce risk. While the supply chain today has made progress in transactional efficiency, companies are less competent at sensing opportunities and mitigating risks.
Risks of Open Payments and Medicare Part D Dataqordata
This SlideShare is aimed at providing a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. Compiled by Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, it will also present information about the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.
Managing The Risk of Open Payments - Validate Spend Report Before CMS Submissionqordata
This presentation is meant to help you understand how you, as a pharmaceutical company, can protect yourself from risks of audit and fines even before you submit your final report to CMS.
Clinical Trial Supply and Logistics Market for Pharma 2018-2028 pharmaceutica...Visiongain
For a report overview of this report please contact sara.peerun@visiongain.com
(+44 (0) 20 7336 6100) or refer to our website: https://www.visiongain.com/Report/2112/Clinical-Trial-Supply-and-Logistics-Market-for-Pharma-2018-2028
With the Trump Administration reducing the size of government and eliminating many regulations, what will 2018 look like for occupational health and safety professionals? The information was garnered from Bloomberg news but the overall emphasis on rule reduction will not go without a challenge in the courts and public advocacy groups. Business needs to realize that people need to come first if their business is to survive in this global marketplace. Collaborating on people, profits, and planet will be key to navigating the choppy waters in the 2018 economy, society, and policy.
This is a Dean's Case Competition project in Som-Binghamton University. I did it with my team in Spring 2014 to present our the overall situation of Medtronic Inc.
Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?
What does the EU Non-Financial Reporting Directive mean for you?FrameworkESG
The European Union recently adopted a directive that will mandate sustainability reporting starting in 2017. Under the new law, a company must report on environmental impacts, social matters, human rights, anti-corruption, and diversity if it meets certain size or classification requirements.
This infographic was originally published at:
http://framework-llc.com/eu-mandates-esg-disclosures/
To find out how your company may need to adapt with increased regulation, contact us: info@framework-llc.com.
On June 21st, PwC’s Health Research Institute (HRI) released its annual Medical Cost Trend: Behind the Numbers 2017 report. PwC’s HRI anticipates a 6.5% growth rate for 2017—the same as was projected for 2016. The report identifies the key inflators and deflators as well as historical context to better understand the medical cost trend for 2017. Increases in the trend due to utilization of convenient care access points and an uptick in behavioral healthcare benefits for employees are being offset by more aggressive strategies by pharmacy benefit
State of Business Networks in Process Industries 2014 - Summary ChartsLora Cecere
Executive Summary
Today, the performance of an organization hinges more than ever on the effectiveness of flows between, and amongst, trading partners. It is not easy. The supply chain is not linear, and the relationships extend across geographic borders and industry sectors.
Outsourcing relationships have grown in the last decade; however, the automation of these networks has not kept pace. In the words of one respondent interviewed for this report in a facilitated workshop to review the data, “Today, we connect trading partners through spreadsheets, email, phone and fax. It is antiquated. I liken it to baling wire, chewing gum and duct tape. I need solutions that can synchronize and harmonize data across trading partners in real-time. My operating committee does not think that it is sexy to invest in B2B solutions, but it is needed. Today, it is almost impossible for us to understand the manufacturing status of purchase orders, and have accurate information readily on supply chain visibility of in-transit shipments. As a result, we make the wrong decisions, and have unnecessary wait times to get information.”
These comments echo the findings in this study. Respondents operate value networks, but they struggle to get to the data they need. The outsourcing of logistics is greater than manufacturing. Eighty-one percent of companies outsource logistics. The volume of outsourced logistics is 48% on average. In contrast, 66% of companies outsource manufacturing. The outsourced volume manufacturing volume varies, but averages 15%.
While the networks are complex, and the goals are many, progress is hard to track. This leads many supply chain leaders to ask, “What is the current state? What is the opportunity?” Answering these questions is the goal of this report.
Let’s start with the current state. As seen in Figure 2, the average respondent in this report believes that the supply chain today is more controlled and global than compared to two years ago. While they have made improvements in agility and proactivity, there is much more left to do. The largest challenges are in the use of outside-in data to improve channel sensing and reduce risk. While the supply chain today has made progress in transactional efficiency, companies are less competent at sensing opportunities and mitigating risks.
Risks of Open Payments and Medicare Part D Dataqordata
This SlideShare is aimed at providing a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. Compiled by Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, it will also present information about the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.
Managing The Risk of Open Payments - Validate Spend Report Before CMS Submissionqordata
This presentation is meant to help you understand how you, as a pharmaceutical company, can protect yourself from risks of audit and fines even before you submit your final report to CMS.
Clinical Trial Supply and Logistics Market for Pharma 2018-2028 pharmaceutica...Visiongain
For a report overview of this report please contact sara.peerun@visiongain.com
(+44 (0) 20 7336 6100) or refer to our website: https://www.visiongain.com/Report/2112/Clinical-Trial-Supply-and-Logistics-Market-for-Pharma-2018-2028
With the Trump Administration reducing the size of government and eliminating many regulations, what will 2018 look like for occupational health and safety professionals? The information was garnered from Bloomberg news but the overall emphasis on rule reduction will not go without a challenge in the courts and public advocacy groups. Business needs to realize that people need to come first if their business is to survive in this global marketplace. Collaborating on people, profits, and planet will be key to navigating the choppy waters in the 2018 economy, society, and policy.
This is a Dean's Case Competition project in Som-Binghamton University. I did it with my team in Spring 2014 to present our the overall situation of Medtronic Inc.
Technology is disrupting the process behind drug development. Growing realization that current clinical trial strategies are not sustainable or feasible means one thing - change. But, where do pharmaceutical companies go from here? An integrated clinical trial ecosystem will arise through leveraging emerging business technologies. But, are companies prepared to take advantage?
Historically, the medical device industry has been highly attractive and relatively stable. As a consequence, established players have been able to compete successfully across the device spectrum, applying common business models and processes without much need for differentiation.
The future, however, is very different as disruptive change is underway. Companies will need to look at new segments and offer end-to-end solutions to secure additional revenue and maintain their profit margins.
Analysis of drivers that cause restricted access to funding for smaller biotech companies.
A detailed reviewed of the steps
venture capitalists and companies are
taking — models such as fail-fast R&D, asset-centric funding and more.
Proposal of a model that
could radically change R&D by taking a
much more holistic approach to drug
development, sharing information to
learn in real time across the cycle of care
and fundamentally changing how risk
and reward are allocated.
The State of Logistics Outsourcing; 2008 Third Party Logistics StudyDennis Wereldsma
This report presents findings from the 2008
13th Annual Third-Party Logistics Study,
which tracks the opinions and experiences
of users of third-party logistics (3PL) services
across the globe.
eDetailing: A Strategic Analysis Of Implementation And ROI (mini)Eularis
Eularis provides a comprehensive insight into the subject of Pharmaceutical detailing using the Internet. As the vast majority of eDetailing pilots have taken place in the US, the report looks at the likelihood of European Pharmaceutical companies following suit. Return on Investment (ROI) is also important. This report discusses the available evidence on ROI and illustrates some models that can be used.
Eularis made extensive efforts to provide the most insightful information about this fast moving subject. This involved:
* Surveying over 200 UK-based general practitioners about their attitudes to Pharmaceutical sales representatives and eDetailing,
* Carefully assessing the current regulatory environment in the UK and how eDetailing programs could be affected,
* Sourcing case studies of ROI from the USA,
* Extensive research into vendor companies and their market positions,
* Strategic considerations and advice.
Serialization: Driving Business Value Beyond ComplianceCognizant
As serialization and track-and-trace capabilities go mainstream to meet regulatory compliance mandates, pharmaceuticals companies should simultaneously explore how these tools and techniques can improve supply chain planning and operations, elevate patient and doctor engagement, and increase sales and marketing effectiveness.
Serialization: Driving Business Value Beyond ComplianceCognizant
Serialization and track-and-trace capabilities are not just useful for meeting regulatory compliance mandates; pharmaceutical companies can also explore their use to improve supply chain planning and operations, elevate patient engagement, and increase sales and marketing effectiveness.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
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
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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
effects (tolerance, withdrawal). This chapter presents an overview
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
pharmacotherapies for AUD.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists
2010 european trends in aggregate spend, transparency and disclosure
1. 2010 European Trends
in Aggregate Spend,
Transparency, and Disclo-
sure
2010 European Trends
in Aggregate Spend,
Transparency, and Disclosure
November 2010
3. e White Paper 3
Life Sciences companies across Europe are facing a
series of emerging global legislation and increased
regulatory enforcement, designed to prevent
corruption and bribery. But how well placed are these
organisations to comply with the need for improved
information transparency and aggregated healthcare
practitioner spend data? And how will the European
regulatory climate compare to the more mature U.S.
regulatory model?
Cegedim Relationship Management has undertaken
its first annual survey into pharmaceutical compliance
activity across Europe. The objective is to continuously
evaluate industry trends and best practices for
operational compliance.
The 2010 regulatory compliance survey reveals Life
Sciences companies across Europe are now very
aware that regulatory compliance and compliance
management is a challenge – a challenge that will
drastically change the way companies behave and
they way they interact with healthcare providers
and customers.
These organisations are also very aware that
compliance with new regulations, such as the UK
Anti-Bribery Act, will have a significant impact
on the industry’s image. Done well, regulatory
compliance should have a very positive effect on
image. However, if one company fails to step up
to the mark and receives high-profile fines, the
industry impact will be very detrimental. As a result,
organisations across the Life Sciences industry are
cooperating and collaborating to determine and
define the standards required.
These companies are certainly looking at the U.S.
regulatory market, with three quarters (75%) of the
respondents believing methods of tracking promotional
spending currently used in the U.S. will be deployed
in Europe. But while European regulators are closely
following the more mature U.S. model, the clear
cultural differences between Europe and the U.S. will
undoubtedly have an impact on the future regulations.
In the U.S., organisations must proactively disclose a
large amount of information; from violations to every
aspect of healthcare practitioner spend, under the
Sunshine Act that comes into effect in 2013, specific
to 2012 interactions with healthcare practitioners
and organizations.
This enforcement model reflects the high levels of
regulation and enforcement applied across every U.S.
industry, from finance to utilities. In Europe, however,
there is a far greater emphasis on self-policing. Life
Sciences companies are being asked by the authorities
to improve information transparency and provide
aggregated spend information. But, at the moment, the
final concept of transparency – and whether it will be
enforced – is still to be determined. However, there is no
doubt that the new regulatory requirements, at global,
regional and local levels will affect the way Life Sciences
companies do business; with 93% of respondents
agreeing that regulatory compliance will be a major
challenge in Europe.
Executive
Summary
93% agree that regulatory
compliance will be a major challenge
in Europe
4. White Paper4
7%
6%
8%
83%Pharmaceutical Company
Medical Device Company
Biotechnology Company
Other, Please Specify
There is little doubt that companies in the U.S. are
ahead of the regulatory curve – perhaps three to five
years ahead of their European counterparts. This
market has been highly regulated for several years, and
the forthcoming Sunshine Act includes even greater
demands for spend transparency. As a result, U.S. Life
Sciences companies are heavily focused on operational
compliance, working hard on the key issues of improving
data quality, meeting regulatory reporting requirements
and vendor management. As this data is compiled,
many are starting to leverage the insights from this
information to share across their organisations to
achieve productivity gains.
By contrast, in Europe, compliance officers are still
determining policy, assessing the implications of global,
regional and local regulatory requirements. Indeed, for
many companies, the process of creating a regulatory
compliance team is still in its infancy.
There are lessons that European companies can learn
from the U.S. that should streamline the regulatory
compliance process and drive down the cost of this
essential but non-core activity. Issues of data quality
remain a massive problem for U.S. Life Sciences
companies, despite the huge investment already made.
It is also important to gain business-wide involvement
in compliance activity – from senior management
commitment, to the IT team that must be involved in
executing the regulatory compliance programme and the
business people who own the data. Indeed, in the U.S.,
after several false starts, it has become apparent that
the most successful regulatory compliance programmes
are owned and driven by business people. Following this
model will help European Life Sciences companies reduce
time to market and the cost of regulatory compliance.
Furthermore, growing numbers of U.S. companies are
turning to dedicated third party solutions for support in
the compliance activity – with around 44% either already
using or planning to take this approach. This survey
reveals that European companies are beginning to follow
suit, although in much smaller numbers.
As the U.S. forges ahead with operational regulatory
compliance projects, it has become apparent that managing
the volume of regulatory change and reconciling diverse
data sources to deliver transparency, is too challenging
to handle internally. The use of third party providers is
becoming key in adhering to policies and procedures while
effectively tracking aggregate spend, identifying suspicious
financial transactions and streamlining regulatory
compliance monitoring.
But there is one area where Europe is already ahead of
the game, at a planning level at least, namely, leveraging
transparency and aggregate spend information to derive
benefits above and beyond compliance. 83% agree the
implementation of transparency guidelines will lead to
better resource allocation; whilst almost two thirds (62%)
agree implementation of transparency guidelines will
generate promotional spend decreases.
This first annual survey provides a fascinating insight into
the nascent regulatory landscape in Europe. It reveals
that Life Sciences companies are investing in regulatory
compliance and assessing policies and procedures. But
it also raises concerns about timing and the need to
extend monitoring beyond traditional sales and marketing
functions. With demands for information transparency
looming, Life Sciences organisations must now move
beyond the planning stage, consider every aspect of spend
and embark upon operational compliance programmes.
Figure 1 - Awareness of Regulatory Compliance Requirements
5. e White Paper 5
Regulatory compliance will grow as a strategic
challenge for the Life Sciences industry within the
next three years with the growing implementation
of new regulatory legislation and compliance
requirements:
93% of respondents agree that regulatory
compliance will be a major challenge in Europe.
Specifically, 82% believe that anti-corruption
regulation (Foreign Corrupt Practices Act, UK
Anti-Bribery Law) will impact the regulatory
environment and global transparency
requirements.
Almost two thirds (62%) agree that the
implementation of transparency guidelines will
generate promotional spend decreases.
The European compliance function is mostly
focused on high-level compliance governance
design and validation – as opposed to the U.S.,
where compliance is being implemented at an
operational level, with an emphasis on data,
reporting and vendor management
The U.S. transparency and aggregate spend model
is likely to spread across Europe, leading to an
increase in companies’ investments
Over half (53%) of respondents anticipate their
investment in aggregate spend transparency to
grow.
Data identification, consistency and quality are
the major challenges in project implementation and
compliance governance processes
22% of companies in Europe are using Excel
today to monitor expenditure. This is set to
drop to 10% as organisations increase their
dependency on third party solutions to meet
compliance requirements.
Organisations in Europe are looking to exploit
greater information transparency to derive further
benefits beyond compliance:
83% agree the implementation of transparency
guidelines will lead to better resource allocation
Key Findings
6%
73%
22%
5%
Somewhat informed
Not at all informed
Very well informed
40%
38%
49%
36%26%
53%
47%
44%
Implementation of transparency guidelines will lead to a better resource allocation.
Regulatory compliance will be a major challenge in Europe.
Completely Agree Mostly Agree
Implementation of transparency guidelines will generate promotional spend decreases.
Regulatory compliance environment will have a major impact on the Life Science industry image.
Figure 2 - Awareness of Regulatory Compliance Requirements Figure 3 - Regulatory Compliance Outlook
6. White Paper6
Whether or not it was merited, there can be no
argument that Life Sciences organisations are now
firmly in the spotlight of anti-corruption and anti-
bribery officials. Global polices regulating promotional
expenditure and sample distributions are being
reinforced, whilst in the U.S. Life Sciences companies
have experienced both dawn raids and serious
investigations by the Department of Justice.
And the implications are significant; pharmaceutical
and medical device companies can face both civil
and criminal sanctions. Siemens was recently fined
more than $1 billion for not maintaining accurate
books of records, while individual executives from
well-established international companies are being
prosecuted for not having implemented enough internal
control and validation measures.
Furthermore, the series of legislation facing Life
Sciences companies continues to grow. The recently
revisited UK Anti Bribery Act comes into force in April
2011 and adds even more complexity to the existing
Foreign Corrupt Practices Act (FCPA), the Organisation
for Economic Co-operation and Development (OECD)
Convention and the Sunshine Act due to come into
force in the U.S. in 2013.
But just how geared up are European Life Sciences
companies for this new regulatory intensity? In the
first annual compliance survey conducted by Cegedim
Relationship Management, the results revealed
some awareness (95%) of the growing regulatory
compliance requirement and the majority (73%) are
very well informed.
Meanwhile, over eight out of ten respondents (82%)
believe the coming anti-corruption regulations, such
as the FCPA and UK Anti-Bribery Law will highly (38%)
or somewhat (44%) impact the regulatory environment.
Less than two out of ten (16%) feel that there will be
low or no impact.
But understanding the extent of that impact remains
a challenge. European Life Sciences companies do
not necessarily want to follow the U.S. route which
will require companies to publish online all spend to
healthcare professionals - both direct and indirect.
This highly-enforced regulatory environment does
not fit comfortably with the European culture of
self-regulation.
However, European regulators are currently looking
closely at the U.S. model to determine the right route
forward and three quarters (75%) of the respondents
believe that methods of tracking promotional
spending currently used in the U.S. will eventually
be deployed across Europe. Approximately one-half
(47%) believe that they will probably come; around
one-quarter (28%) believe that they are likely to
come. And just one in ten (10%) believe that they are
not coming.
Certainly organisations are aware of the implications
of escalating compliance demands. 93% of respondents
agreed that regulatory compliance will be a major
challenge in Europe; and 93% also say the regulatory
Introduction
82% believe the coming
corruption regulations will impact the
regulatory environment
7. e White Paper 7
compliance environment will have a major impact on
the Life Sciences industry image.
However, it is apparent that despite well-publicised
regulatory compliance recruitment programmes, the
responsibility for compliance in Europe still rests
primarily with sales and marketing teams. 117
individuals contributed to the research; 83% of these
were from pharmaceutical, 8% medical device and 6%
biotechnology companies.
Just 26% of respondents, however, have a
dedicated regulatory compliance role; while 29%
are in marketing and 18% in sales. In contrast in
the U.S., 32% of respondents were in compliance
and 21% in operations; just 14% were in marketing
and 13% in sales.
However, it is good to note that in the European
research, 7% are in general management; 5% in
finance/audit; 4% in public/government affairs
and 4% in medical, demonstrating the growing
realisation that compliance must become a part
of the daily business life across every part of the
pharmaceutical organisation.
The emphasis on sales and marketing personnel
taking control of regulatory compliance requirements
also reflects the fact that the European marketplace
is still focused heavily on tracking sales and
marketing spend to healthcare professionals rather
than every aspect of spend, such as support for
clinical trials which also will demand input from R&D
and public affairs.
Furthermore, while the majority (88%) of these
individuals have a direct involvement in mandate
marketing and promotional spend laws, only 51% are
very involved in healthcare professionals
spend tracking and monitoring process based
on existing laws and legislations. In the U.S., by
comparison, 69% of respondents were very involved
in spend tracking and monitoring. No doubt the
level of European involvement will increase as the
compliance function in Europe becomes more mature.
29%
26%
18%
7%
5%
4%
4%
3%
2%
2%
10%
Marketing
Compliance
Sales
Management (General)
Finance/Audit
Public/Government Affairs
Medical
Legal
Technical Operations (IS)
R&D
Other
Figure 4 - Report Participant Demographics
8. White Paper8
Understanding
Compliance
So how confident are these organisations in achieving
fast emerging regulatory compliance demands?
According to the research, almost three-quarters
(73%) of the respondents say that their company is
either excellently (31%) or well equipped (42%) to
comply with transparency regulations as they exist
today. Just one quarter (25%) feels that their company
is fairly (22%) or poorly (3%) equipped to deal with
transparency regulations.
This compares with just 29% of companies in the U.S.
believing the organisation is either excellently or well
equipped to comply. This clearly reflects the different
levels of maturity in the U.S. and the very strong culture
of enforcement: in the U.S., organisations have to
demonstrate regulatory compliance to what are far more
stringent regulations that span the entire organisation,
not just the sales and marketing role; whilst in Europe
there are, as yet, no best practice guidelines or
benchmarks for regulatory compliance activity.
Given that far more stringent regulations are expected
in Europe shortly, the results suggest a worrying level
of complacency amongst organisations. And those
that only rate their ability to comply as ‘fair’ today, in
what is a relatively unregulated environment, should
be particularly concerned about how they will address
compliance at global, regional and local levels over the
coming 12-18 months.
The research also revealed that organisations are
still developing strategies to deliver effective
transparency projects. Indeed, when asked to
describe their role in the company’s involvement with
locally-mandated marketing and promotional spend
compliance, the majority of respondents (60%) said
they were directly involved with process design and
implementation.
Approximately four out of ten are involved with data
analysis (44%) and report review and approval (39%);
approximately three out of ten are involved with
tracking legislative updates (30%) and gathering and/
or entering of data (25%); while approximately two in
ten are involved in report generation (19%), processing
data (18%), vendor selection (16%) and vendor
management (15%).
In contrast, U.S. Life Sciences companies are three
to five years ahead with the implementation of
operational-based compliance solutions, with a far
higher emphasis on areas such as data processing,
report generation and vendor selection.
It is understandable that these European organisations
are focusing attention on understanding the regulatory
compliance requirements, particularly since local
and regional interpretations of regulations vary. The
differences can range from not bribing “public officials”
– a term that itself can be interpreted differently
across the globe depending on the way health services
are delivered; to the new Anti-Bribery Law that
includes both private and public Healthcare sectors in
the UK. This law also has far tougher sanctions than
other legislation: an individual convicted for failing
to implement adequate measures now faces up to 10
years in prison and unlimited fines.
U.S. Life Sciences companies are
three to five years ahead with the
implementation of operational-base
compliance solutions
9. e White Paper 9
Furthermore, each country has a different limit for the
amount of promotional spend allowed per official – for
example, small gifts cannot exceed £6 in the UK, but
€30 in Spain or 100 zloty in Poland. And even the use
of samples is significantly reduced, with organisations
now complying with the ‘four times two’ standards
– no more than four samples per physician for two
years after the product’s launch – laid down by the
European Federation of Pharmaceutical Industries and
Associations (EFPIA).
Despite this complexity, the survey highlighted
opportunities associated with compliance activity
– most notably the value of creating and providing
aggregated spend information to the business as
a whole. Some 83% agree the implementation of
transparency guidelines will lead to better resource
allocation; while almost two thirds (62%) agree
implementation of transparency guidelines will
generate promotional spend decreases.
These figures make it clear that organisations
across Europe are already looking to derive benefits
beyond compliance from this investment by better
understanding the deployment of resources in terms of
both people and investment. This contrasts heavily to
the U.S. where there has traditionally been a clear line
between compliance and the business: organisations
in the U.S. are only now beginning to look at attaining
possible business benefits from regulatory compliance
data. The business-based attitude of the European
market should enable companies not only to embed
compliance activity in every part of the organisation
but also derive additional benefits faster.
3%
22%
42%
31%Excellent
Good
Fair
Poor
Figure 5. Ability for Company to Comply with Transparency Regulations Today
10. White Paper10
Given the awareness of the importance of regulatory
compliance activity to the Life Sciences industry, just
how committed are these organisations to investing in
the right people, processes and technologies to drive
successful compliance programmes?
Over half (53%) of respondents anticipate their investment
in solution and resources to provide aggregate spend
transparency to grow, reflecting the growing awareness of
the compliance risk across both the industry and Europe.
And of the 40% that expect investment to stay the same,
the majority of respondents are in country-based, rather
than regional roles revealing a gap between local and
regional compliance understanding.
So how will this investment be made? Today over half
(56%) are using internal software systems to monitor
company expenditure in Europe; and 22% are reliant
on manual processes and Excel spreadsheets; with just
10% using a dedicated third party solution. When asked
how the company planned to satisfy spend transparency
requirements tomorrow, there is a significant shift away
from manual processes. Indeed, just 10% plan to use
Excel in the future. Instead, 56% will use internal software
systems; and 19% will use third party solutions.
Given the comparative sophistication of the U.S.
marketplace, it is interesting to see how attitudes to
monitoring aggregate spend compare. Today in the
U.S., some 40% are still reliant on Excel, 32% use
internal software systems, 24% third party solutions
and 4% do not monitor at all. In the future, the
majority (44%) plan to adopt dedicated third party
software; 31% will use internal software systems, while
17% plan to remain with Excel.
Certainly this shift away from manual processes is
critical. The new regulatory implications extend far
beyond traditional detailing activity and embrace
every part of the organisation that has any kind of
customer interaction, from engaging with customers
in clinical trials, to providing grants to physicians or
simply inviting a Key Opinion Leader to a progress
meeting. Also companies will have to include all
payments made on their behalf by external partners
and third parties companies.
Therefore, pharmaceutical companies now need to
track every interaction and financial transaction,
monitor both direct and indirect payments undertaken
on behalf of the organisation, and then reconcile the
expenses to each physician or official.
This process becomes even more complex when
considering the multi-national nature of most Life
Achieving
Compliance
Figure 6. Anticipation of Level of Investment on
Aggregate Spend Level for Next Year
3%
11%
40%
42%Increase
Stay the same
Significant increase
Decrease
83% Agree the
implementation of transparency
guidelines will lead to better resource
allocation
11. e White Paper 11
Sciences company operations: organisations have to
put in place global guidelines and consistent standards
to monitor closely all interactions with healthcare
professionals. They have to be able to reflect the
different regulations in each country; and they need
to achieve this without incurring an unmanageable,
expensive overhead.
This huge shift towards third party software, especially
in the U.S., is a clear indication of the need for support
in designing and implementing robust processes for
creating aggregated spend data that encompasses more
than just sales and marketing expenditures.
In Europe, Customer Relationship Management (CRM)
provides companies with an easy route to collate the
sales and marketing aspect of spend information.
The significant numbers of organisations looking to
adopt third party solutions in the U.S. demonstrates
recognition that when organisations have to include
information from R&D, medical affairs and third party
vendors, there is a need for external support in areas
such as data management and aggregation. As the
compliance model in Europe becomes more mature,
it is very likely the same patterns of third party
software adoption will be followed.
And a fundamental component of this process is the
creation of a unique customer record – a problem that
has been extremely understated, even in the mature
U.S. market. Pulling information from multiple, diverse
systems - from ERP to third party vendors - and
ensuring spend is reconciled to a single, accurately
identified customer, is a significant challenge. Customer
data will be often incomplete and recorded differently
in each system. How can an organisation ensure that
Dr. Brown is the same Dr. Patrick Brown, or hospital
consultant Pat Brown in Manchester?
U.S. companies are investing heavily in creating
excellent customer Master Data Management (MDM)
systems, the core component of the transparency
process. Yet just 15% of U.S. companies are very
confident in the ability of the internal customer MDM
system to define the unique recipient records across all
spend sources; with 31% somewhat confident.
In Europe, by contrast, where organisations have yet
to embark upon the creation of MDM, one quarter
(25%) of respondents are very confident in the ability
of internal systems to define the unique recipient
record across spend sources or across countries;
while 37% are only somewhat confident. Again, this
difference reflects the sales and marketing emphasis
of the European compliance activity to date, with
companies reliant upon and confident in the quality
of their CRM systems.
However, true transparency will require cross-system
information provision and failure to define the unique
recipient (customer) record across all spend sources or
across countries will lead to the failure of the entire
compliance project.
Figure 7. Functions to Ensure Compliance with Local Mandated Marketing and Promotional Spend Regulation
60%
44%
39%
30%
25%
19%
18%
16%
15%
13%
Process design and implementation
Data Analysis
Report review and approval
Tracking legislative updates
Gathering and/or entry of data
Report generation
Processing data
Vendor selection
Vendor management
Other, please specify
12. White Paper12
Data Challenge
This issue is reflected in the concerns raised in
response to complying with FCPA and regulations
such as the OECD convention and UK Anti-Bribery.
The greatest concern is collecting all relevant spend
data (39%), followed by data integrity (36%) and
identification of spend recipients (36%) and preparing
reports for data disclosure (34%).
Given that Life Sciences companies in Europe will
have to report accurately on this data within the
next 12-18 months notably in the U.S. and UK, it
is clear that organisations must focus hard up-
front on enhancing data management governance
before embarking upon any further regulatory
compliance activity.
However, when asked ‘what are the key issues that
impact the level of regulatory compliance,’ organisations
cited lack of understanding of policy (62%) as the
primary impact. Lack of policy knowledge leads to errors
in data, therefore organisations need to embark upon
company-wide education and training programmes to
reinforce the importance of compliance and FCPA to the
pharmaceutical business – and the market as a whole.
It is no surprise that poor record keeping or data entry
errors is the next most significant impact (54%), given
the need for high quality data to achieve compliance;
if individuals do not understand the policies and
procedures, or recognise the need for ethical
behaviour, poor record keeping and data errors will be
inevitable. Improving education should, by default, lead
to better information.
The third most important impact is system process
shortcomings (52%). But as the need for a unified,
strategic global compliance strategy and view becomes
more important, the shortcomings of existing systems
for monitoring and reporting aggregate spend will
become even more evident.
The way in which information is captured is just half
the problem. In the U.S. just 37% of respondents
indicate that their company enforces corporate
standards for healthcare professional and spend data
capture which applies to all suppliers and staff. The
remaining respondents either do not have standards or
have standards which are not used universally.
In Europe, however, where the market is significantly
less regulated, some 83% of organisations enforce
corporate standards for healthcare professionals and
Figure 8. Areas of Concern Complying with the FCPA and Anti-Corruption Regulations
36%
39%
36%
34%
30%Handling inquiries after spend is posted
Prepare reports and analysis for potential data disclosure
Proper identification of spend recipients
Data Integrity - having accurate, certified, complete,
and timely data
Collecting all relevant spend data
13. e White Paper 13
spend data capture. The majority (62%) have standards
that apply to all external parties and internal data;
whilst only 21% have standards that only apply to
some external parties and internal data. Just 7% of
organisations currently have no standards and are not
in the process of defining any.
Where enforced, these standards apply to
honorarium fees (71%); promotional spend (75%) and
consultancy fees (68%). Third party data (38%) is
less commonly covered.
These figures are very revealing. The strong
emphasis on sales and marketing related spend
underlines the relative immaturity of the European
market when compared to the U.S. – and reflects the
very different enforcement models applied in these
markets.
The challenges associated with collecting and collating
this data reflect the problems already encountered in
the U.S.; issues include managing disparate formats
and standards (37% challenging) and establishing
unique identification of healthcare professional from all
the expense data sources (35% challenging), identifying
all data sources (32%) and managing incomplete spend
information (31%).
The implications of these problems are significant.
A lack of consolidated customer view created by the
inability to uniquely identify a healthcare professional
from diverse expense data sources will lead to
inaccurate monitoring and reporting, and a risk
of compliance breach. But with multiple source
systems and owners, file format differences and
numerous third party sources, even identifying all
the sources before creating the unique customer
number is a massive challenge. Add in global
regulatory compliance needs and the complexity
increases significantly
Figure 9. Does your Company Enforce Corporate Standards for Healthcare Professionals and Spend Data Capture
Figure 10. How Challenging are the Following Processes?
3%
7%
21%
62%Yes, applies to all the external
and internal data
Yes, but applies only to external
partners and
internal systems
No, we do not have standards
No, but we are in the process
of defining one
0%
No, looking for a vendor
to provide a solution
31%
32%
35%
37%Managing disparate formats
and standards
Matching and establishing
unique identification of a
Healtcare Professional from
all the expense data sources
Identifying all data sources
Managing incomplete spend
and customer information
14. White Paper14
Robust Model
If organisations are to achieve a consistent, global
model for regulatory compliance, it is essential to
create a standard data capture model that also
supports local rules to ensure every market is managed
consistently and effectively. As a dire imperative,
organisations need to consider not only spend
aggregation but also robust and thorough customer
data management.
One option is to put in place an aggregate spend
solution that builds on existing Key Account
Management (KAM) information to automate and
streamline regulatory compliance monitoring and
reporting. It is by leveraging this strong, accurate
data source and integrating a wide range of
enterprise applications for Sales Force Automation,
ERP, Finance and HR, that organisations can
streamline and automate the process of highlighting
suspicious transactions.
Using Business Intelligence, Life Sciences companies
can not only conduct the required in-depth historic
analysis but also put in place proactive alerts both
for individuals identified as highly influential and also
if payments to specific practitioners are about to hit
the threshold (Fair Market Value); preventing both
intentional and accidental compliance breaches.
There is a further component to compliance activity,
namely transparency. In this global operating
environment organisations are increasingly looking
at opportunities to drive best practice, create global
policies with local implementation and improve
processes and key to this is to improve transparency.
This regulatory compliance drive is now enabling
organisations to collect and share information not only
with government and regulators but also internally.
Indeed, the wealth of financial information collected
to achieve compliance provides valuable insight into
cross-organisational spend with specific healthcare
providers. Adding customer data management to the
process provides a depth of information that can
be analysed to assess value, understand how much
is being spent at an individual level and improve
resource allocation.
This improved insight also has implications for Key
Account Managers. The aggregate spend information
can be analysed to provide a Key Account Manager
with insight into spend at a local level, such as
investment in training or continuous medical education
(CME) to a physician. With a complete picture of the
investment by organisation, a Key Account Manager
embarking upon negotiation for a new bid or new
customer is in a far stronger position to demonstrate
the value being provided by the Life Sciences company.
This is a powerful tool that, if used correctly, should
have a direct, bottom line impact on business.
Using Business Intelligence,
companies… can put in place
pro-active alerts. Preventing
both intentional and accidental
compliance breaches
15. e White Paper 15
Conclusion
Transforming the image of the Life Sciences
industry will take time. But the commitment being
demonstrated today is extremely positive. And
whilst organisations are obviously keen to avoid the
negative publicity, fines and possible court cases
associated with bribery and corruption, there is no
doubt that organisations in Europe are also looking to
derive benefits from improved transparency, whether
for internal compliance reasons or external disclosure.
With a real opportunity for a Life Sciences company
to establish a good image to the healthcare market,
the industry is increasingly considering transparency
as a huge competitive advantage and benefit, and
an opportunity to improve resource utilisation,
rather than simply an expensive and time-consuming
overhead expense.
But, while the commitment is not in doubt,
organisations are still struggling to actually deliver
transparency, both from a technology and business
model perspective. This is a multi-disciplinary project
that is not just about exploiting technology but also
about driving new behaviour change and imposing
compliance as a change in ethical behaviour to the
customer.
Critically, global regulatory compliance and
transparency demands an automated and streamlined
solution: not only are the costs of a manual or
spreadsheet approach too high, but without some
kind of automation and built-in alerts that reflect the
different countries’ interpretations, organisations will
be exposed to a high risk of compliance breach.
Regulatory compliance is becoming a key function
within the Life Sciences business; indeed it is, in
some companies, becoming a cornerstone of how
business is conducted and is massively influencing
the commercial model. But for the industry to achieve
wholesale changes in attitude and perception, every
organisation needs to commit. Without that, European
Life Sciences companies will face the highly enforced
model being adopted in the U.S., rather than a self-
policing approach – a model that many fear will
significantly undermine customer relationships.
Now is the time to work with other organisations in
the field to develop best practices, to assess how
to best leverage existing spend capture sources
and resources, and to put in place procedures and
practices that will mitigate both the risk and cost
associated with global compliance.
Authored by;
Bill Buzzeo
VP and GM of Global Compliance Solutions
Cegedim Relationship Management
william.buzzeo@cegedim.com
Guillaume Roussel
VP Compliance Solutions EMEA
Cegedim Relationship Management
guillaume.roussel@cegedim.com
Exclusive Survey Results on
Life Sciences Industry
Regulatory Compliance
Trends...
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16. White Paper16
2010 European Trends
in Aggregate Spend,
Transparency, and Disclosure
For more information, please contact
compliance@cegedim.com
www.cegedim.com/eucompliance
2010 Cegedim, Inc. All Rights Reserved
Reproduction and distribution of this report is allowed only with the written authorisation from Cegedim.White Paper16
2010 European Trends
in Aggregate Spend,
Transparency, and Disclosure
For more information, please contact
compliance@cegedim.com
www.cegedim.com/eucompliance
2010 Cegedim, Inc. All Rights Reserved
Reproduction and distribution of this report is allowed only with the written authorisation from Cegedim.