Two colleagues and I were featured in the winter 2010 edition of GLOBAL DEVELOPMENT CONNECTIONS (a Bayer HealthCare internal newsletter) as experts in and advocates of Good Publication Practice.
Bericht des Vorstands 2013 der Bundesvereinigung Logistik (BVL) e.V.BVL International
Das Jahr 2013 war für die Bundesvereinigung Logistik ein doppeltes Jubiläumsjahr: Der Verein wurde 35 – und zum 30. Mal fand in Berlin der Deutsche Logistik-Kongress statt. Das Jahresthema und Motto des Kongresses lautete „Impulse, Ideen, Innovationen“. Ganz bewusst wurde so das Jubiläum mit Themen der Zukunft begangen – zum Nutzen der Mitglieder, die im großen Netzwerk der BVL Informationen, fachlichen und kollegialen Austausch sowie Unterstützung suchen und finden. Lesen Sie hier im "Bericht des Vorstands" alles über die Leistungen und Tätigkeiten des BVL im vergangenen Jahr.
Bericht des Vorstands 2013 der Bundesvereinigung Logistik (BVL) e.V.BVL International
Das Jahr 2013 war für die Bundesvereinigung Logistik ein doppeltes Jubiläumsjahr: Der Verein wurde 35 – und zum 30. Mal fand in Berlin der Deutsche Logistik-Kongress statt. Das Jahresthema und Motto des Kongresses lautete „Impulse, Ideen, Innovationen“. Ganz bewusst wurde so das Jubiläum mit Themen der Zukunft begangen – zum Nutzen der Mitglieder, die im großen Netzwerk der BVL Informationen, fachlichen und kollegialen Austausch sowie Unterstützung suchen und finden. Lesen Sie hier im "Bericht des Vorstands" alles über die Leistungen und Tätigkeiten des BVL im vergangenen Jahr.
Krishna Voice Magazine is a English publication circulated on a Monthly basis. Download latest Krishna issue voice from https://www.iskconbangalore.org
Comprehensive information on our vision and mission, products and services that we deal with and some of the projects that we have undertaken for our clients.
Currículum de Ing. Roddy Macías Párraga (roddymacias@gmail.com)
Profesional con amplia experiencia en gestión ambiental: Manejo de Áreas Naturales Protegidas, prevención y control de la contaminación ambiental, y aplicación de la normativa ambiental ecuatoriana.
Experiencia directa en la gestión pública de la gestión ambiental, asesoría a empresas públicas y privadas.
Ingeniero Civil con experiencia en obras para el desarrollo con énfasis en saneamiento ambiental, en infraestructura comunitaria y en aprovechamiento sustentable y de bajo impacto ambiental en áreas silvestres: áreas protegidas públicas, bosques protectores, bosques privados y comunales.
Preparado para desarrollar soluciones creativas en un ambiente exigente y conflictivos, con destrezas en vocerías enfocadas a fortalecer la imagen institucional, buen manejo con medios de comunicación y redes sociales.
Pay at-the-Table / Bringing Payments to the ConsumerIngenico Group
Restaurants, hotels, casinos, stadiums and other hospitality businesses see a lot of payment transactions and in most cases, the servers/staff take the credit card away from the customers to process the payment. This payment experience is starting to change – and for good reason.
Join our payments experts for this recorded webinar, entitled Pay-at-the-Table / Bringing Payments to the Consumer, to:
-Take a deep dive into the pay-at-the-table solution
-Gain insight into what’s driving the transition in the U.S.
-Learn the various ways businesses can benefit from pay-at-the-table, including EMV-readiness, increased efficiencies and NFC-enablement
-Explore pay-at-the-table use cases and opportunities
-Discover what solutions are available and determine which ones are right for your business
-Hear best practices for transitioning to pay-at-the-table
Nikken fue creada en Japón en 1975, basada en un invento que relajaría y energizaría a millones de personas que padecían uno de los problemas más comunes de los seres humanos: dolor de pies y la fatiga. Este invento nació del conocimiento ancestral de la relajación que producen las pequeñas piedras redondas que cubren el fondo de las tinas de las casas de baños termales japonesas, y a esto se le incorporó magnetismo. Así nació Magstep, el primer producto de Nikken. Las plantillas Magsteps son un ejemplo de una idea innovadora: ofrecer soluciones de bienestar basadas en el mundo natural. Pero la motivación de la compañía iba más allá de los productos. Un genuino interés por los demás y de ayudar a las personas era y sigue siendo fundamental dentro de la visión corporativa. De este modo, nace la filosofía de la empresa que hoy ha sido adoptada por millones de personas alrededor del Mundo.
Oscar Padilla Verazaluce
Consultor Nikken
Celular : 975385128
RPM: *0143240
Skipe : opadillav
Email: opadillav@gmail.com
Facebook : https://www.facebook.com/pages/Nikken-Per%C3%BA/205145686189416
Youtube : http://www.youtube.com/user/opadillav
ICH Guidelines Effective for Regulating Quality of Medicines?Ajaz Hussain
ICH Guidelines: Effective tools for regulating the quality of medicines? Enabling regulatory considerations – the ICH Q8 – 12 are such considerations. Effective implementation of enabling regulatory considerations is a challenge. The challenge is what we know and what we can implement are two different things. Education, training, and experience linked to measures of professional development, as it relates to PQS, should bridge what we know and what we implement. What are such measures? Some corporations are already focused on making their PQS effective (e.g., Amgen) but most are not. In a global supply chain (with ~ 90% of Rx being generics) this can pose a major challenge to deliver assurance patients need. Why? #education #medicine #assurance #regulations #globalization #corporations #bridging #measurements
Krishna Voice Magazine is a English publication circulated on a Monthly basis. Download latest Krishna issue voice from https://www.iskconbangalore.org
Comprehensive information on our vision and mission, products and services that we deal with and some of the projects that we have undertaken for our clients.
Currículum de Ing. Roddy Macías Párraga (roddymacias@gmail.com)
Profesional con amplia experiencia en gestión ambiental: Manejo de Áreas Naturales Protegidas, prevención y control de la contaminación ambiental, y aplicación de la normativa ambiental ecuatoriana.
Experiencia directa en la gestión pública de la gestión ambiental, asesoría a empresas públicas y privadas.
Ingeniero Civil con experiencia en obras para el desarrollo con énfasis en saneamiento ambiental, en infraestructura comunitaria y en aprovechamiento sustentable y de bajo impacto ambiental en áreas silvestres: áreas protegidas públicas, bosques protectores, bosques privados y comunales.
Preparado para desarrollar soluciones creativas en un ambiente exigente y conflictivos, con destrezas en vocerías enfocadas a fortalecer la imagen institucional, buen manejo con medios de comunicación y redes sociales.
Pay at-the-Table / Bringing Payments to the ConsumerIngenico Group
Restaurants, hotels, casinos, stadiums and other hospitality businesses see a lot of payment transactions and in most cases, the servers/staff take the credit card away from the customers to process the payment. This payment experience is starting to change – and for good reason.
Join our payments experts for this recorded webinar, entitled Pay-at-the-Table / Bringing Payments to the Consumer, to:
-Take a deep dive into the pay-at-the-table solution
-Gain insight into what’s driving the transition in the U.S.
-Learn the various ways businesses can benefit from pay-at-the-table, including EMV-readiness, increased efficiencies and NFC-enablement
-Explore pay-at-the-table use cases and opportunities
-Discover what solutions are available and determine which ones are right for your business
-Hear best practices for transitioning to pay-at-the-table
Nikken fue creada en Japón en 1975, basada en un invento que relajaría y energizaría a millones de personas que padecían uno de los problemas más comunes de los seres humanos: dolor de pies y la fatiga. Este invento nació del conocimiento ancestral de la relajación que producen las pequeñas piedras redondas que cubren el fondo de las tinas de las casas de baños termales japonesas, y a esto se le incorporó magnetismo. Así nació Magstep, el primer producto de Nikken. Las plantillas Magsteps son un ejemplo de una idea innovadora: ofrecer soluciones de bienestar basadas en el mundo natural. Pero la motivación de la compañía iba más allá de los productos. Un genuino interés por los demás y de ayudar a las personas era y sigue siendo fundamental dentro de la visión corporativa. De este modo, nace la filosofía de la empresa que hoy ha sido adoptada por millones de personas alrededor del Mundo.
Oscar Padilla Verazaluce
Consultor Nikken
Celular : 975385128
RPM: *0143240
Skipe : opadillav
Email: opadillav@gmail.com
Facebook : https://www.facebook.com/pages/Nikken-Per%C3%BA/205145686189416
Youtube : http://www.youtube.com/user/opadillav
ICH Guidelines Effective for Regulating Quality of Medicines?Ajaz Hussain
ICH Guidelines: Effective tools for regulating the quality of medicines? Enabling regulatory considerations – the ICH Q8 – 12 are such considerations. Effective implementation of enabling regulatory considerations is a challenge. The challenge is what we know and what we can implement are two different things. Education, training, and experience linked to measures of professional development, as it relates to PQS, should bridge what we know and what we implement. What are such measures? Some corporations are already focused on making their PQS effective (e.g., Amgen) but most are not. In a global supply chain (with ~ 90% of Rx being generics) this can pose a major challenge to deliver assurance patients need. Why? #education #medicine #assurance #regulations #globalization #corporations #bridging #measurements
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
The following are some of the latest subjects discussed in GPP3:
• The most recent ICMJE authorship conditions are explained (2013)
• Authorship problems that are frequently found
• Author payment and repayment are now more explicitly described.
• Clarification of the words "ghost fiction" and "guest authorship."
• Professional medical writers: what they do and how they help
• Advice on how to exchange data acceptably.
Continue Reading: https://bit.ly/2OOiUNI
Reference: https://pubrica.com/services/publication-support/
Why Pubrica:
When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
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The Industry Familiarisation Book provides an in-depth analysis of the industry setting for the case study. This book helps students develop a sound commercial awareness of the industry, which is an essential element to analysing options and providing recommendations.
An introduction on Evidence-Based Clinical Practice Guidelines in Health Care Organizations
Brief on Alexandria Center for EBCPGs in Alexandria University Hospitals, Egypt
By Dr. Yasser Sami Abdel Dayem Amer, MBBCh, MS 2013
Special Thanks to
Prof Dr Mahmoud Elzalabany
Prof Dr Tarek Omar
Prof Dr Nabil Dowidar
Prof Dr Afaf Gaber
OxfordSM's pharma case studies - providing a call to actionOxfordSM
Brand teams have to be increasingly innovative when finding ways to prompt patients and physicians to intervene at the right time.
Campaigns such as GSK’s Greatest Season Ever for FLONASE®, implemented last year in the United States which made the decision to prepare for the allergy season easier for patients by linking the proactive purchase of the brand to the start of the baseball season.
Providing A Call To Action:
We find that examples from within and outside of healthcare can often prompt this innovation. They act as a way of bringing in new perspectives and allowing teams to explore new avenues and new ideas.
So, in the spirit of hoping this will prompt some new ideas in your brand team, here are our favourite case studies that speak to the need to provide a call to action.
How True Open Innovation TM and its global network can expand the opportunity for drug development by increasing efficiency and decreasing costs
Luca Rastelli, PhD
Boston Strategics Corporation
October, 2013
These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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
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
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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!
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Surgical Site Infections, pathophysiology, and prevention.pptx
Our Commitment to Good Publication Practice
1. GLOBAL DEVELOPMENT
connections
WINTER 2010 VOL. 3, NO. 4
L I N K I N G T H E G L O B A L C O M M U N I T Y
Xarelto® Wins Country
11th Taking Spotlight:
9 International
Prix Galien 10 Quality to a
new level 17 The Russian
Federation
2. Table of Contents
3 A Message from Kemal Malik
5 Feature Story
A Quick Look Back and Full Speed Ahead
for Bayer HealthCare Pharma’s Oncology Business
8 Event
US FDA Approves the First Contraceptive Pill Fortified with Folate
9 Event
Xarelto® Wins the 11th International Prix Galien
for Best Pharmaceutical Agent
10 GD Organization Spotlight
Taking Quality to a New Level
12 GD Asia Hub Update
Biostats GD Asia overview
13 Leadership
A discussion on Leadership with Joachim Schmidt,
Head Global Operations & Branded Generics
15 Operational Excellence
New Standard Operating Procedure
Raises the Bar for Observational Studies
17 Country Spotlight
The Russian Federation: A Core Part of Bayer’s Emerging Market Strategy
19 Employees Speak Out
What is a recent accomplishment of Global Development Russia
that you are especially proud of ?
20 Customer First
Bayer HealthCare Pharma’s Global Publication Policy
Outlines Our Commitment to Good Publication Practice
22 Key Links
u2
3. u CUSTOMER FIRST
Bayer HealthCare Pharma’s Global
Publication Policy Outlines Our
Commitment to Good Publication Practice
For the past two years, the Scientific Communications team within Global Medical Affairs has been leading a Best Practices
initiative, which has reached a major landmark of completing a Global Publication Policy for the Pharma division which will
be published soon on www.bayerscheringpharma.de. GD Connections talked to members of the team responsible for the
new policy.
The past couple of years have seen heightened scrutiny and criticism of the GD Connections spoke with Chris James, Scientific Publications and Information
pharmaceutical industry’s publication practices, particularly with regard to “hot Management; Tricia Gooljarsingh, PhD, Publications and Medical
topics” such as the timeliness of scientific publications, criteria for authorship, Communications; and John Zoidis, MD, Publications and Communications ,– as
acknowledgement of editorial and writing support (“ghost authors and ghost well as the sponsor – Richard Nieman, MD, now Head of Medical Affairs Asia – to
writers”), and conflicts of interest. Although learn how and why this initiative was launched.“It wasn’t a question of changing
Bayer HealthCare itself has not been the target how we do things within Bayer – we have been following good publication
of any public criticism, its Scientific practice all along,” said James. “We developed this policy not only to ensure that
Communications teams nonetheless wanted we are doing the right thing, but also to be able to
collectively to ensure the company continues show that we are.” Dr. Gooljarsingh, added that
to adhere to Good Publication Practice (GPP) "our commitment to good publication
standards and that its policy for scientific practices will reinforce in a very public way,
publications remain transparent. our commitment to the healthcare
Hence the rollout of the Global community - to provide valuable
Publication Policy, which is based information from our trials in a
on prevailing GPP guidelines such compliant and ethical manner.”
as the International Committee of
Medical Journal Editors (ICMJE)
Uniform Requirements1 and the
GPP guidelines developed by the
International Society for Medical
Chris James,
Publication Professionals (ISMPP).2
Tricia Gooljarsingh, PhD,
and John Zoidis, MD
u 20
4. u CUSTOMER FIRST
u Collaborative effort the forefront of good publication practice, and will allow the organization to be
To develop the policy, the team of James, Gooljarsingh and Zoidis, and others proactive instead of reactive when it comes to adhering to ever-changing GPP
working on scientific publication management formed a Good Publication Practice standards. We meet regularly to discuss GPP issues, identify any changes in the
working group that began meeting regularly to share best practices and practical GPP landscape, and render any due diligence recommendations we believe are
experiences and to discuss key issues. Over time, the group developed a series of necessary. We want Bayer to lead by example when it comes to GPP adherence.”
recommendations, based on current GPP guidelines and practices, for how Bayer
“It is because the external guidelines, and thus prevailing standards for GPP,
HealthCare Pharma should best handle scientific publications. The cornerstone of
continue to evolve that it is important to ensure everyone working to communicate
these recommendations was the creation and publication of the Global Publication
our clinical trial results is aware of GPP and the potential criticisms we face if we
Policy. Dr. Nieman (who at the time was based in Montville as Head of Global
fail to meet these standards,” added James.
Medical Affairs for Therapeutic Areas) presented these recommendations to Bayer
HealthCare Pharma’s Board of Management, which endorsed them in May. “We have such a great pipeline of products like Xarelto®, Eylea™ and others in
development, which makes publishing information about our clinical trials all the
In the context of the policy, “publication” means all non-promotional, product-
more important,” Dr. Nieman added. “When we have such good information to
related, scientific publications, including abstracts, posters, review articles, peer-
share, it’s key to have a good process in place for doing that.”
reviewed primary and secondary study manuscripts developed for publication in
biomedical journals, and presentations at scientific congresses and other external 1 International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted
meetings. to biomedical journals: writing and editing for biomedical publication. Updated April 2010. Accessed
December 1, 2010. Available at: http://www.icmje.org/urm_main.html.
“One of the things we recommended was that all publication activities be 2 Graf C, Battisti WP, Bridges D, et al. Good publication practice for communicating company
coordinated by Medical Affairs,” Dr. Nieman said. Medical Affairs has taken the sponsored medical research: the GPP2 guidelines. Br Med J. 2009;339:b4330.
lead, he explained, “because our function is all about communicating the safety,
efficacy and value of our products, so we need our scientific information to be of
the highest quality.” Added Dr. Nieman, “The policy also reiterates Bayer The GPP Working Group
HealthCare’s commitment to disclosing accurate and balanced information about
the design and results of its clinical trials and its adherence to strict ethical Chris James Philipp Lengsfeld / Kimberly Boothe
standards regarding authorship of scientific publications.” GMA NOH Petra Palkowitsch US RMA
GMA Diagnostic
u Evolving landscape John Zoidis Cynthia Guerra
Imaging
Dr. Zoidis noted that GPP is a constantly changing landscape. “This policy GMA Oncology US RMA
demonstrates the Pharma division’s alignment with the current standard for quality Kathrin Stauch
control and due diligence in ensuring that every aspect of our business is up to Tricia Gooljarsingh Elisabeth Operschall
GMA NIS
these standards, and demonstrates in a completely transparent fashion that we’re GSA Hemophilia GSA Avelox
Gerlind Holberg
keeping an eye out on these standards as they continue to evolve,” he said. It will Elvira Baumann
GMA Rivaroxaban
be the task of the GPP Working Group (Table) to monitor changes to GPP (Bettina Althoff)
standards and make recommendations to ensure ongoing adherence. Added Dr. GMA Female Healthcare Ralf Winnen
Zoidis, “The GPP Working Group will continue to ensure that Bayer is always at MA Bayer Vital
u 21