This presentation on the process of making PrEP available in Australia was given by Anna Roberts, Deputy CEO, Division Manager Policy and Education, ASHM, at the AFAO Members Forum – May 2015.
Presentation by Bill Gunnyeon, director for health work and wellbeing and chief medical adviser, at the CBI's employee health & absence conference. London, June 2010.
SBIR 101 by InterKn - Everything you need to know about America's Seed FundStem
Are you developing innovative technology? Are you looking for funding for your R&D? Are you interested in pursuing an SBIR or STTR opportunity but aren't sure where to start? You've come to the right place! At InterKn, our mission is to educate entrepreneurs and researchers about alternative innovation funding. In this short presentation, we discuss everything you need to know about the SBIR Program and how you can use it to fund your project past proof-of-concept and on to a commercially viable product! For more free information on innovation funding resources, visit us at https://www.interkn.com.
Professor Stephen Roper . International Conference . Taiwan. Experimenting wi...enterpriseresearchcentre
Presentation by Professor Stephen Roper to International Conference - Taiwan.
Experimenting with industrial policy: The UK’s experience of industrial policy making using randomised control trials (RCTs)
Presentation by Vittorio Lusvarghi, chair of the Professional Accountants in Business Committee Sustainability Task Force, at the Institute of Cost Accountants of India's National Cost Convention, New Delhi, India, March 2012.
This presentation on the process of making PrEP available in Australia was given by Anna Roberts, Deputy CEO, Division Manager Policy and Education, ASHM, at the AFAO Members Forum – May 2015.
Presentation by Bill Gunnyeon, director for health work and wellbeing and chief medical adviser, at the CBI's employee health & absence conference. London, June 2010.
SBIR 101 by InterKn - Everything you need to know about America's Seed FundStem
Are you developing innovative technology? Are you looking for funding for your R&D? Are you interested in pursuing an SBIR or STTR opportunity but aren't sure where to start? You've come to the right place! At InterKn, our mission is to educate entrepreneurs and researchers about alternative innovation funding. In this short presentation, we discuss everything you need to know about the SBIR Program and how you can use it to fund your project past proof-of-concept and on to a commercially viable product! For more free information on innovation funding resources, visit us at https://www.interkn.com.
Professor Stephen Roper . International Conference . Taiwan. Experimenting wi...enterpriseresearchcentre
Presentation by Professor Stephen Roper to International Conference - Taiwan.
Experimenting with industrial policy: The UK’s experience of industrial policy making using randomised control trials (RCTs)
Presentation by Vittorio Lusvarghi, chair of the Professional Accountants in Business Committee Sustainability Task Force, at the Institute of Cost Accountants of India's National Cost Convention, New Delhi, India, March 2012.
All EU institutions support a better alignment between Horizon 2020 and other EU Programmes. In particular the alignment and complementary use of research funding and structural funds is encouraged. It is expected that the Commission will require regions to dedicate regional funds to e.g. innovation and education. Horizon 2020 will also interact with the COSME Programme targeting SMEs in order for SMEs participating in Horizon 2020 to obtain funding for market application and commercialization of research results.
It is good governance for a public sector entity to
define the interests of all stakeholders and develop an
understanding of the role that stakeholders have in or
with the entity.
Benefits of stakeholder engagement
Stakeholder engagement benefits for the public sector
entity include:
• increased efficiency in and effectiveness of service
• improved risk management practices — allows risks
to be identified earlier, thereby reducing future costs
• streamlined policy and program development
processes
• greater engagement with stakeholder interests —
ensuring services are delivered in collaboration with
stakeholders and provide outcomes which meet
community needs
• enhanced community confidence in the public sector
• enhanced capacity to innovate.
Who are the stakeholders?
The public sector entity should identify and understand
all affected stakeholders, their distribution and their
needs and interests. It is good governance for a
public sector entity to strive to bring the voice of the
stakeholder into the business in order to build trust
and confidence in the entity and facilitate better
community outcomes.
Monitoring and Evaluation of International Development Assistance to the Priv...CesToronto
Effective monitoring and evaluation (M&E) systems are essential to learning and accountability. M&E system reviews provides perspective on what is working well, where there are gaps in coverage or weaknesses that need to be addressed, how the M&E information is actually used in decision making, and whether the system is efficient. This session will demonstrate the methods, tools and results in assessing the functioning of the M&E systems of the World Bank Group’s private sector operations in two specialized agencies: the International Finance Corporation and the Multilateral Investment Guarantee Agency.
Introduction to stakeholders and material issuesMeghan Ennes
Stakeholders activate issues, but which stakeholders impact or are impacted by your business? And what environmental and social issues should you prioritize? In this workshop, we explore steps to identify your key stakeholders and prioritize your—and—their top issues. These tools are instrumental to identifying material issues and offer the foundation for creating an aligned corporate citizenship strategy that provides value for your company.
The Industry funded IIT from the CRO perspective: Optimizing the interface between the industry and the Sponsor- Investigator.
Presented by Ran Frenkel, CEO, Pharma Focus Israel at the First European Investigator Initiated Trials Conference in Barcelona, Spain.
This module discuss in detail Business Environment Definition, Strategically Important Components, Components of External Environment, Political Environment, Economical Environment, Socio Cultural Environment, Technological Environment, Natural Environment, Legal Environment, Demographical Environment, Industry’s Dominant Economic Features, Competitive Analysis, Porter 5 Force Model, Sixth Force of Porter 5 Force Model, Strategic Group, Strategic Group Analysis, Analysis of Company’s Resources, Capability and Competitive Position, SWOT Analysis, TOWS Analysis, Internal Analysis Definition, Steps in Internal Analysis, Resource Audit, Value Chain Analysis, Building Core Competency, BCG Matrix and Approaches to Internal Analysis.
Private sector has taken a much larger role in development interventions that ever before. This presentation outlines the Monitoring and Evaluation systems used by the International Finance Corporation and the Multilateral Guarantees Agency (MIGA) as well as how the Independent Evaluation Group assesses the effectiveness of these systems. Main messages of this presentation are:
- Private Sector operations have specific data gathering advantage/disadvantage based on their business model
- M&E systems should adopt to the business practices to be effective and efficient
- M&E can influence learning, quality of work and outcome
CSO Partners in collaboration with CII conducted a CSR Online Educational Series exclusively for NGOs. This is the second presentation in the series
It covers the following topic
- CSR Provision Applicablility
- CSR Policy and Reporting
- Program Sectors
- Scope for NGO Partnership
- Financial Allocation
All EU institutions support a better alignment between Horizon 2020 and other EU Programmes. In particular the alignment and complementary use of research funding and structural funds is encouraged. It is expected that the Commission will require regions to dedicate regional funds to e.g. innovation and education. Horizon 2020 will also interact with the COSME Programme targeting SMEs in order for SMEs participating in Horizon 2020 to obtain funding for market application and commercialization of research results.
It is good governance for a public sector entity to
define the interests of all stakeholders and develop an
understanding of the role that stakeholders have in or
with the entity.
Benefits of stakeholder engagement
Stakeholder engagement benefits for the public sector
entity include:
• increased efficiency in and effectiveness of service
• improved risk management practices — allows risks
to be identified earlier, thereby reducing future costs
• streamlined policy and program development
processes
• greater engagement with stakeholder interests —
ensuring services are delivered in collaboration with
stakeholders and provide outcomes which meet
community needs
• enhanced community confidence in the public sector
• enhanced capacity to innovate.
Who are the stakeholders?
The public sector entity should identify and understand
all affected stakeholders, their distribution and their
needs and interests. It is good governance for a
public sector entity to strive to bring the voice of the
stakeholder into the business in order to build trust
and confidence in the entity and facilitate better
community outcomes.
Monitoring and Evaluation of International Development Assistance to the Priv...CesToronto
Effective monitoring and evaluation (M&E) systems are essential to learning and accountability. M&E system reviews provides perspective on what is working well, where there are gaps in coverage or weaknesses that need to be addressed, how the M&E information is actually used in decision making, and whether the system is efficient. This session will demonstrate the methods, tools and results in assessing the functioning of the M&E systems of the World Bank Group’s private sector operations in two specialized agencies: the International Finance Corporation and the Multilateral Investment Guarantee Agency.
Introduction to stakeholders and material issuesMeghan Ennes
Stakeholders activate issues, but which stakeholders impact or are impacted by your business? And what environmental and social issues should you prioritize? In this workshop, we explore steps to identify your key stakeholders and prioritize your—and—their top issues. These tools are instrumental to identifying material issues and offer the foundation for creating an aligned corporate citizenship strategy that provides value for your company.
The Industry funded IIT from the CRO perspective: Optimizing the interface between the industry and the Sponsor- Investigator.
Presented by Ran Frenkel, CEO, Pharma Focus Israel at the First European Investigator Initiated Trials Conference in Barcelona, Spain.
This module discuss in detail Business Environment Definition, Strategically Important Components, Components of External Environment, Political Environment, Economical Environment, Socio Cultural Environment, Technological Environment, Natural Environment, Legal Environment, Demographical Environment, Industry’s Dominant Economic Features, Competitive Analysis, Porter 5 Force Model, Sixth Force of Porter 5 Force Model, Strategic Group, Strategic Group Analysis, Analysis of Company’s Resources, Capability and Competitive Position, SWOT Analysis, TOWS Analysis, Internal Analysis Definition, Steps in Internal Analysis, Resource Audit, Value Chain Analysis, Building Core Competency, BCG Matrix and Approaches to Internal Analysis.
Private sector has taken a much larger role in development interventions that ever before. This presentation outlines the Monitoring and Evaluation systems used by the International Finance Corporation and the Multilateral Guarantees Agency (MIGA) as well as how the Independent Evaluation Group assesses the effectiveness of these systems. Main messages of this presentation are:
- Private Sector operations have specific data gathering advantage/disadvantage based on their business model
- M&E systems should adopt to the business practices to be effective and efficient
- M&E can influence learning, quality of work and outcome
CSO Partners in collaboration with CII conducted a CSR Online Educational Series exclusively for NGOs. This is the second presentation in the series
It covers the following topic
- CSR Provision Applicablility
- CSR Policy and Reporting
- Program Sectors
- Scope for NGO Partnership
- Financial Allocation
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
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
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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
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!
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Light House Retreats: Plant Medicine Retreat Europe
Ensuring the transparency of expert patient contributions
1. An agency of the European Union
Declarations of Interest (DoI)
EURORDIS Summer School 2018
2. Objectives of the policy
• Main objective of the policy is to ensure that the scientific committees’
members and experts participating in the Agency’s activities have no
interests in the pharmaceutical industry that could affect their impartiality,
as per the requirements of EU legislation (Article 63(2) of Regulation (EC) No
726/2004).
• This has to be balanced with the need to secure the best expertise.
1
3. Requirements for involvement in EMA activities
• Up-to-date DoI validated by the expert
• Up-to-date e-CV (tick box option for patients) required to validate eDOI
• Expert Nomination form (tick box option for patients)
Expert must be included in Experts database prior to first involvement
Applicable to experts participating in product related face-to-face meetings,
teleconferences and written consultations
2
4. e-DoI and eCV
• Valid for 1 year
• Includes confidentiality undertaking
• If interests change, must submit updated e-DoI/eCV
• All declarations of conflict of interest (DoI) and eCVs are published on the EMA website in
the European experts list
3
5. Elements of the DoI/Confidentiality form
SECTION 1: PERSONAL DETAILS
SECTION 2: PUBLIC DECLARATION OF INTERESTS
• 2.1 Employment
• 2.2 Consultancy
• 2.3 Strategic advisory role
• 2.4 Financial interests
• 2.5 Principal investigator
• 2.6 Investigator
• 2.7 Grant / Funding to organisation/institution
• 2.8 Close family member interest
• 2.9 Any other interests or facts
SECTION 3: CONFIDENTIALITY UNDERTAKING
4
6. Two categories of interests are defined
Direct interests in pharmaceutical industry are:
• Employment with a company
• Consultancy to a company
• Strategic advisory role for a company
• Financial interests
Indirect interests in pharmaceutical industry are:
• Principal investigator
• Investigator
• Grant or other funding to an organisation/institution
Definitions cannot address all the scenarios which may exist; additional guidance included
in “Procedural guidance on inclusion of declared interests in the EMA’s electronic DOI form
(EMA/627294/2014, Rev. 1).
5
7. Direct interests Indirect interests
Employment at a company
(currently or within the last 3 years)
Principal investigator
(currently or within the last 3 years)
Consultancy for a company
(currently or within the last 3 years)
Investigator
(currently or within the last 3years)
Strategic advisory role for
a company
(currently or within the last 3 years)
Institution/organisation currently receives
grant/funding with direct benefit to the expert
Current financial interests (personal shares, fees,
honoraria, patents, …
Not reasonable expenses for conference)
Close family member currently has interest in a
company (employment, consultancy, strategic
advisory role, financial)
6
8. Consultancy for a pharmaceutical company
Is defined as….
any activity where the concerned expert provides advice (including
training on a one to one basis) to a pharmaceutical company
regardless of contractual arrangements or any form of remuneration.
7
9. Strategic advisory role for a pharmaceutical company
Defined as….
any activity where the expert is participating (with a right to vote/influence the
outputs) in a(n) (scientific) advisory board/steering committee
with the role of providing advice/expressing opinions on the (future) strategy,
direction and development activities of a pharmaceutical company, either in
terms of general strategy or product related strategy,
regardless of contractual arrangements or any form of remuneration.
8
10. Grant or other funding to an organisation/institution
Shall mean: any funding received from
a pharmaceutical company by an organisation/institution to which the expert belongs, or for
which he/she performs any kind of activity, and which is used to support any activity of the
expert whether or not it is related to research work.
9
Patients :
• Who are volunteers with their organisation do not have to include funding related to their
organisation on their DOI (2.7), unless they are committee or working party members /
alternates.
• who are employees of their organisation do have to include funding related to their
organisation on their DOI under 2.7.
11. Other declarable interests
‘Other Interests or Facts’ to be declared (no restrictions apply)
• Involvement in academic trials
• Involvement in publicly funded research/development initiatives
• Membership of ethics committees
No need to declare
• Attendance at courses and conferences funded by companies
Unless: payment beyond reimbursement of reasonable expenses (i.e.
accommodation and travel cost), this is considered as current financial interest
10
12. 11
Status
Length of
involvement
(in years)
Committee /
WP member
Committee /
WP Expert
SAG member / Expert
Employee
(depends on whether
executive role, lead role or
cross company role)
Current No involvement No involvement No involvement
0 to 3
Restrictions Restrictions Restrictions
>3
Restrictions Restrictions Restrictions
Consultancy/
Strategic Advisory Role
(depends whether cross
product / general or
individual)
Current No involvement No involvement
Restrictions
0 to 3
Restrictions Restrictions Restrictions
Financial Interest Current No involvement No involvement No involvement
0 to 3
Full involvement Full involvement Full involvement
Grant / funding to
organisation / institution
Current
Restrictions Full involvement Full involvement
0 to 3
Full involvement Full involvement Full involvement
Close family member Current
Restrictions Full involvement Full involvement
0 to 3 Full involvement Full involvement Full involvement
13. Any questions? Maria Mavris
Patient Liaison
Public Engagement Department
maria.mavris@ema.europa.eu
www.ema.europa.eu
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5550
Send a question via our website www.ema.europa.eu/contact
12
Editor's Notes
All experts, including patient and consumer representatives, need to complete some forms before they can be involved in the Agency's activities. This is particularly important for activities related to the assessment of medicines.
It is a legal requirement – EMA is scrutinised on this topic
EMA must demonstrate the anyone involved in our activities is not also involved or has a link with industry
Anyone who participates in an EMA activity is considered an EMA expert– not only members and alternates of committees but patients too
We have an EMA policy that applies to all experts – can be found on website… clear explanations of what we are referring to and how to fill in..
Must be nominated to participate – EMA can also nominate a person as an expert – you must fill in a nomination form and submit – as well as an electronic curriculum vitae…
