13th Pharmacovigilance 2017
Offering our customers the knowledge and connections for a profitable business
Speakers
  • FATEMEH NOURI. E

    FATEMEH NOURI. E FDA

  • DEEPA ARORA

    DEEPA ARORA Lupin (India)

  • KHAUDEJA BANO

    KHAUDEJA BANO Abbott

  • BRIAN DREYFUS

    BRIAN DREYFUS Bristol-Myers Squibb

  • CARMIT STRAUSS

    CARMIT STRAUSS Amgen

  • BEN LOCWIN

    BEN LOCWIN Healthcare Science Advisors

  • MICK FOY

    MICK FOY MHRA (UK)

  • REEMA MEHTA

    REEMA MEHTA Pfizer

  • VLADIMIR PENKRAT

    VLADIMIR PENKRAT Wipro

  • NAGHMANA BAJWA

    NAGHMANA BAJWA Shire

  • ESTHER DE LA CUESTA

    ESTHER DE LA CUESTA Takeda Pharmaceuticals

  • JOHN SOLOMON

    JOHN SOLOMON Sanofi

  • ANKA G. EHRHARDT

    ANKA G. EHRHARDT Bristol-Myers Squibb

  • BARBARA DA SILVA-TILLMANN

    BARBARA DA SILVA-TILLMANN Abbvie

  • MELVA T. COVINGTON

    MELVA T. COVINGTON Pacira Pharmaceuticals

  • GEORGE VAN BAELEN

    GEORGE VAN BAELEN Shire

  • NAMRATA SINGH

    NAMRATA SINGH Turacoz Healthcare Solutions (India)

  • CLAYTON DEHN

    CLAYTON DEHN Clinical Trials of Texas

  • MARTIN H. BLUTH

    MARTIN H. BLUTH Consolidated Laboratory Management Systems (CLMS)

  • SHEILA WEISS

    SHEILA WEISS Evidera

  • SHEETAL KHEDKAR

    SHEETAL KHEDKAR Sarah Cannon Development Innovations

  • ROBERT S. WALSH

    ROBERT S. WALSH Walsh Medical Consulting

27th & 28th September 2017, Holiday Inn Chicago O’Hare, USA

“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”

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CONFERENCE INTRODUCTION:- 

Global Pharmacovigilance Market expected to Reach US$6.1 bn by 2020 expanding at a CAGR of 14.2% from 2015 to 2020 and also expected to reach a market size of $8.23 billion by 2022.

Medicinal products changed the way in which diseases are achieved and controlled in the current era of medical technology. Regardless of the benefits, Adverse Drug Reactions (ADRs) continue to rise leading to illness, disability and even death of the patients. Globally, ADRs are one of the leading causes of mortality. Monitoring and evaluation of drug safety becomes vital in order to enhance public health, which requires a (PV) system in place. Globalization and free trade explosion have changed the way individuals today access medicinal products. Therefore, effective collaboration is required between pharmaceutical organizations and the key pv players in order to minimize the risks associated with the use of medicines. By 2020, the size of the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia and Turkey. The rapid induction in the market throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. Along with clinical trials Bioavailability and bioequivalence studies also plays major role in clinical research. The global market for Biopharmaceuticsin 2013 was $305.1 million, which is expected to reach about $326.3 million by year-end 2014. The projected PAT instrumentation market is expected to be valued at around $450.6 million by 2019 at a compound annual growth rate (CAGR) of 6.7% for the period of 2014 to 2019

13th Annual Pharmacovigilance 2017 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.  The entire program will cover the detection, analysis and prevention of adverse drug reactions.  It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pv requirements, and to improve their organizations' compliance with pv requirements. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv development. What does the future hold for pv? Find out at our conference on opportunities and activities shaping pv to 2020 with respect to regulations, technologies and services. Learn and know on what are drug producers and service providers doing? What regulations and technologies influence the current pv field? You can also discover at 13th Pharmacovigilance 2017 on spending forecasts for pv (US, the EU and Asia).

It gives me great pleasure in welcoming all of you to the Virtue Insight’s 13th Pharmacovigilance 2017.  I wish and pray that all our efforts will be beneficial to our industries and to our country at large.

 

KEY THEMES:-

  • Establishing and streamlining pharmacovigilance in the US: where are we heading? 
  • Updates towards of legislation, policies, systems, technology, communication strategies and best practice in PV 
  • Analyzing the Challenges and Opportunities to optimize the overall PV ecosystem
  • Why does pharmacovigilance sometimes fail and where
could the fault lie?
  • Pharmacovigilance and the assurance of Artificial Intelligence
  • Updates from the Office of Surveillance and Epidemiology (OSE) within CDER.
  • Postmarketing safety monitoring within OSE
  • Pharmacovigilance and healthcare system
  • Revised GVP guidance on signal management – how to implement?
  • Updates to PSUR, PBRERs, DSUR, PASS
  • Review the various data sources available in post-marketing setting and their pros & cons
  • Good Clinical Practices and Good Pharmacovigilance practices
  • Future of outsourced phase I, II and III trials and post-marketing studies, inc. pharmacovigilance
  • Emerging technologies to efficiently collect, store and analyze data in a comprehensive data management system
  • Strategies to improve clinical trials and PV
  • Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
  • Patient centric approach to help improve patient safety
  • Outsourcing activities - How to set it right?
  • PV Audit & inspections - preparation, implementation and lessons to be learnt
  • Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
  • Outsourcing Vs In-House
  • The effect of Brexit on Pharmacovigilance
  • Current regulations and guidelines - USA and EU PV
  • The developing regulatory framework in advanced and developing markets
  • Accelerating new medicine introduction in developing world & overcoming challenges
  • Be part of a major networking opportunity

 

WHO SHOULD ATTEND:-

CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:

  • Pharmacovigilance 
  • Pharmacoepidemiology
  • Pharmacogenomics
  • Drug/Product Safety
  • Drug Development
  • Information and Clinical Data Management
  • Clinical Pharmacology
  • Clinical Safety
  • Periodical safety update Reports
  • Risk Management
  • Research & Development
  • Quality Assurance
  • Patient Safety
  • Signal Detection
  • Safety Surveillance
  • Outcomes Research
  • Data Analysis
  • Epidemiology
  • Medical Affairs
  • Regulatory Affairs and Compliance
  • Information technology
  • Sales and Marketing 

 

WHY SHOULD YOU ATTEND:-

13th Pharmacovigilance 2017 – “Uniting “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management"

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway.  Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks
ROBERT S. WALSH, Consultant, Walsh Medical Consulting

MARKET TRENDS & WAY FORWARD

09:40 – Morning Keynote Address 1 - How can mobile technologies and social media support drug safety?

  • The latest findings and policy recommendations from the WEB-RADR project
  • Next steps for mobile Apps in PV
  • New ways to visualise pharmacovigilance data

MICK FOY, Group Manager, MHRA (UK)

QUALITY - SAFETY

10:20 – Decipher the final Post-Market Safety Reporting (PMSR) Rule for combination products

  • Products – definition
  • What does the final rule expect? Key concepts
  • Case-scenario of a simple combination product

KHAUDEJA BANO, Senior Medical Director, Medical Affairs, Abbott

10:50 –
Reality and Roadmap to PV Automation

The emergence of advancing technologies such as Artificial Intelligence (AI), Robotics Process Automation, Natural Language Processing, Smart OCR, etc are demonstrating great potential across industries. The approach toward application in the PV space is showing traction but is still little understood in applying best practices and considerations toward the change implementation. This topic will focus on capabilities in these advancing technologies, limitations, and best practices toward a managed roadmap starting with defined clear objectives toward achieving PV automation.

VLADIMIR PENKRAT, Client Partner Pharmaceutical & Medical Device, Wipro

11:10 – Morning Coffee/Tea & Discussion


CHALLENGES & OPPORTUNITIES


11:30 – Keynote Panel Discussion: Challenges and Opportunities – Optimize the overall PV ecosystem for maximum benefit

  • Staying ahead in the race - Update on PV in EU, USA & RoW - Current trends for PV, and new and future guidelines
  • Globalization of Pharmacovigilance
  • Pharmacovigilance - The effect of Brexit
  • Comparison of Pharmacovigilance in the US, , Latin America, Asia, Caribbean and Europe
  • How to create a proactive drug safety culture?
  • What can we learn from successful experiences from RoW?
  • Where is the market heading and what needs to be done?  
  • Brexit and the impact on Pharmacovigilance

Moderator:
ROBERT S. WALSH, Consultant, Walsh Medical Consulting

Panellists:
FATEMEH NOURI. E, Postdoctoral Fellow, FDA
KHAUDEJA BANO, Senior Medical Director, Medical Affairs, Abbott
REEMA MEHTA, Senior Director, Head of Risk Management Center of Excellence, Pfizer
NAMRATA SINGH, Director,  Turacoz Healthcare Solutions (India)

OUTSOURCING 


12:10 – Outsourcing Vs In-House

  • Preliminary set up steps – what are all to be looked into?
  • Moving forward – what are the deals that are to be communicated
  • Steps to be taken in order to maintain efficacy and quality
  • Monitoring constantly and effects of proper communication
  • Benefits and risks of managing a pharmacovigilance-outsourced organization

NAMRATA SINGH, Director, Turacoz Healthcare Solutions (India)

12:40 – Networking luncheon


13:50 – Global integration of pharmacovigilance services - Latin America and the Caribbean
GEORGE VAN BAELEN, Head Pharmacovigilance Latin America & Carribean, Shire

PRE-CLINICAL & CLINICAL TRAILS
 

14:30 – Are those side effects due to my drug? The case for clinical laboratory toxicology and drug testing in clinical trials

  • The opioid epidemic has changed the landscape of clinical treatment approaches
  • Side effects of pharmaceuticals affect drug launch, recalls, and post market economics
  • Laboratory toxicology and drug testing can identify unreported narcotic / analgesics that may contribute to clinical trial results

MARTIN H. BLUTH, Chief Medical Officer, Consolidated Laboratory Management Systems (CLMS)

15:10 Afternoon Tea/Coffee

15:30 – Safety Reporting in Licensing Agreements

DEEPA ARORA, Vice President- Pharmacovigilance & Global Head- Drug Safety & Risk Management,
Lupin (India)


TECHNOLOGY IMPACT


16:10 –
What it Takes to Bring Complex Technologies to the Everyday Study

  • Example flow cytometry
  • Impact of operational challenges
  • Technological developments overcoming these challenges
  • Future vision

ANKA G. EHRHARDT, Director Clinical Cytometry, Biomarker Technologies, ECTR, Bristol-Myers Squibb

16:50 Chairperson’s closing remarks and end of conference

ROBERT S. WALSH, Consultant,
Walsh Medical Consulting


17:00 – 18:00 Networking Drinks Session

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks
BEN LOCWIN, President, Healthcare Science Advisors

SIGNAL DETECTION

09:40 – Morning Keynote Address 1 – Pharmacovigilance through a Products Life Cycle

  • Building the continuum of pharmacovigilance across premarketing and post-marketing

                 o    Challenges in clinical trials
                 o    Challenges postapproval

  • Targeted event collection
  • Strengthening the link between a drug and its related adverse events from pre-clinical to post-marketing
  • Future of outsourced phase I, II and III trials and postmarketing studies, inc. pharmacovigilance

ESTHER DE LA CUESTA, Senior Medical Director, Pharmacovigilance, Takeda Pharmaceuticals


BUSINESS MODELS

10:20 – Social media and pharmacovigilance

  • How does social media fit into the standard pharmacovigilance workflow
  • How does social media compare to FAERS and administrative claims
  • What are some other areas of potential for social media (e.g. drug abuse)

BRIAN DREYFUS, Director, Bristol-Myers Squibb

   
11:00 – Morning Coffee/Tea & Discussion


SPONSOR – SITE – CRO - PATIENTS

11:20 – Keynote Panel Discussion – Maintaining proper communicaton between - Sponsor – Site – CRO & Patients

  • Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
  • Directions or recommendations on reporting and unblinding clinical trial safety reports to authorities, investigators, and IRBs
  • Achieving harmonisation – How are we working together to improve drug safety
  • Patients involvement for a better PV knowledge - Patient support programs
  • Customer engagement programs - add value and support pharmacovigilance practices
  • Benefit-risk evaluation: the past, the present and the future
  • Pharmacovigilance and risk management planning


Moderator:
BEN LOCWIN, President, Healthcare Science Advisors

Panellists:
MELVA T. COVINGTON, Senior Director, Health Outcomes & Value Assessment, Pacira Pharmaceuticals
ANKA G. EHRHARDT, Director Clinical Cytometry, Biomarker Technologies, ECTR,
Bristol-Myers Squibb

BARBARA DA SILVA-TILLMANN, Senior Medical Director, Abbvie
SHEETAL KHEDKAR, Senior Director, Regulatory Science,
Sarah Cannon Development Innovations

 
PV RISK MANAGEMENT & PLANNING

12:00 – How to incorporate the patient voice and develop effective risk minimization tools
CARMIT STRAUSS, Global Risk Management Scientist / Safety Management – GPS, Amgen

12:40 Networking luncheon

13:50 –
"Pharmacovigilance: A collaborative approach"
NAGHMANA BAJWA, Sr Med Dir, Global Medical Affairs Hematology Lead, Shire


14:30 – Patient centric pharmacovigilance - How this can be improved and related risk minimisation strategies.

JOHN SOLOMON, Head of Pharmacovigilance-UK & Ireland, Sanofi


15:10 – Afternoon Tea/Coffee

REGULATORY


15:30 – Does Real World Evidence have a role in Pharmacovigilance?

  • Real-world evidence expanding role in regulatory decisions
  • Signal detection in a target-poor environment
  • RWE in pharmacovigilance

SHEILA WEISS, Senior Research Leader, Evidera


16:10 – Reviewing the phenomenons of increased risk of ketoacidosis and amputation related to SGLT inhibitive therapy
CLAYTON DEHN, Senior Vice President, Early Phase Services & Strategic Development, Clinical Trials of Texas

 
16:50 17:00 – Chairperson’s closing remarks and end of conference
BEN LOCWIN, President, Healthcare Science Advisors

FATEMEH NOURI. E

Postdoctoral Fellow

FDA

I really enjoy in vitro and in vivo research approaches, including molecular and cellular biology, genetic, pharmacological methods, gene delivery and biochemistry. I would like to work on Pluripotent stem cells in disease modelling, cell culture systems for drug discovery and toxicity testing based on the mechanism of cell signaling pathways. I am also interested to investigate early and reliable biomarkers for diseases and work in the therapeutic development area, since I have experience on biomarker discovery.

My background is on neurochemistry and neurophysiology of neurodegenerative diseases like Parkinson’s disease (PD) that aimed at finding a biomarker for PD. I also have good understanding and background in Genetics and I enjoy identifying novel genes that regulate biological functions and identifying mutations that lead to diseases. Currently I am working in a cancer lab to examine the ability of some drugs in treatment of triple negative breast cancer and pancreatic cancer.  Previously I have worked on a project evaluating Cerium oxide nanoparticles (nanoceria) promise as neuroprotective agent in MPP treated SH-SY5Y cells. Learning and trying new methods and keeping updated with the latest skills beside what I already know are something that I really follow. This may help me to develop my knowledge and understanding of biology and preparing myself to be a faculty member.

I am very motivated to do high quality research and willing to work very hard and generate data in addressing pressing questions in the field of unknown pathogenic processes underlying disease. I desire to be productive in a research team that each member has a key role on a project and with opportunity to collaborate with others.

DEEPA ARORA

Vice President - Pharmacovigilance & Global Head- Drug Safety & Risk Management

Lupin (India)

KHAUDEJA BANO

Senior Medical Director, Medical Affairs

Abbott

Khaudeja is a Physician with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, an Oracle Database Administrator and a certified Project Management Professional.  She is an Abbott President’s award winner, avid Toastmaster and certified coach.  Khaudeja has more than 25 years professional experience, including clinical practice. She has held several global safety positions at Guidant, Abbott (Vascular, Diagnostics, and Established Pharma Division), and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

BRIAN DREYFUS

Director

Bristol-Myers Squibb

CARMIT STRAUSS

Global Risk Management Scientist / Safety Management - GPS

Amgen

Carmit Strauss, PharmD, is currently a benefit risk management scientist at Amgen. Carmit obtained her PharmD at the University of Southern California and completed her industry Post-Doctoral fellowship in medical affairs at Baxter Bioscience. Dr. Strauss has a global medical affairs and medical communications experience in Hematology, Oncology, Immunology, Lysosomal diseases, Pulmonology and Neurology. She also has a safety and Pharmacovigilance experience in Hematology and Lysosomal diseases.

Dr. Strauss has worked at Baxter as an associate director in Medical Affairs and provided medical expertise to the different stakeholders. She contributed to the development of risk management strategy and creation of product risk management plans, safety updates safety assessment reports for all hematology products. Carmit also worked for Protalix Biotherapeutics as the Pharmacovigilance lead of the company.  In her current role Dr. Strauss provides expertise and practical guidance on risk management plan development, risk communication and risk minimization design, implementation and evaluation, structured benefit-risk assessment, patient-centered approaches and methodologies.

BEN LOCWIN

President

Healthcare Science Advisors

Dr. Ben Locwin is an international speaker and expert on healthcare strategies and development programs to increase business performance and improve patient-centricity and patient safety. He has been featured in The Wall Street Journal, Forbes, The Associated Press, and other media outlets. His work has created some of the current best practices in pharmacovigilance and risk management which have improved drug outcomes and regulatory success across clinical trials.

Dr. Locwin is a member of the Advisory Board for ATD's Healthcare Community of Practice, which is helping to improve healthcare practices worldwide. He also serves as an expert media contact for the American Association of Pharmaceutical Scientists (AAPS). On Twitter:@BenLocwin

MICK FOY

Group Manager

MHRA (UK)

Mick Foy has been with the MHRA for more than 30 years, he has been manager of the Vigilance Intelligence and Research Group for 10 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is also responsible two large European projects to improve drug safety monitoring. The EC funded SCOPE (Strengthening Collaborations to Operate Pharmacovigilance in Europe) Joint Action aims to improve the pharmacovigilance capabilities of national regulators in Europe, and the Innovative Medicines Initiative funded WEB-RADR (Recognising Adverse Drug Reactions) project seeks to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.
Mick also leads the MHRA’s international strategy with regard to pharmacovigilance capacity building.
Mick is also a member of the MedDRA Management Board

REEMA MEHTA

Senior Director, Head of Risk Management Center of Excellence

Pfizer

VLADIMIR PENKRAT

Client Partner Pharmaceutical & Medical Device

Wipro

NAGHMANA BAJWA

Sr Med Dir, Global Medical Affairs Hematology Lead

Shire

Naghmana has over 18 years of multinational varied academic, CRO and industry experience including creating teams, establishing Safety and Medical Affairs functions, clinical research, data management, Business Development, Regulatory, Commercial  and global pharmacovigilance, risk management & Pharmacoepidemiology. In addition, have expertise in due diligence and assessing suitability for clinical trial from pre-clinical data as well as for in-licensing projects and in preparing for and managing Global Regulatory Agency inspections.

Most recently Naghmana has held positions of increasing responsibility at Shire Global Medical Affairs and Abbvie Medical Services. She has implemented Risk Minimization plans and effectiveness assessments globally. She has been nominated for the Global International Talent List, Women Leadership and Senior Manager’s Leadership tracks. Naghmana’s medical training focused on General Surgery. She earned her MD degree from Fatima Jinnah Medical College Lahore in Pakistan. She has been an invited speaker at several Drug Safety, Risk Management and eCTD conferences.

ESTHER DE LA CUESTA

Senior Medical Director, Pharmacovigilance

Takeda Pharmaceuticals

Esther De La Cuesta obtained her MD from the University of St. Thomas in the Philippines. She has a Masters in Business Administration (MBA), Healthcare from Penn State University in Pennsylvania, USA.

Esther started her career in Clinical Research in Rhone Poulenc Rorer as Medical Safety Officer, R &D Oncology supporting the submission activities for NSCL and Gastric CA as well as working on compounds in development for new indications and marketed products life cycle management. Since then she has gained experiences in Medical Affairs, Business Development and Medical Monitoring. Her experiences covers all phases of clinical development, drug safety and epidemiology, and developing risk management strategies to support submissions, product launches and post marketing safety management for multiple therapeutic areas. She also has international experience interacting with multiple Regulatory Authorities including FDA, EMA, HC, MHRA, and BfArM.

She has held positions of increasing responsibility and of strategic importance at Bristol Myers Squibb, Abbott Laboratories, where she was the first Filipino Female medical executive, and Vertex Pharmaceuticals, was a Senior Medical Director, Disease Area Safety Head leading a group of safety personnel as they navigate the post approval period for their marketed products.After serving as Senior Medical Director, Global Medical Safety, Pharmacovigilance at Takeda Pharmaceuticals International, she has recently joined the Marketed Products Group as Senior Medical Director, Clinical Science Lead.

Esther has been involved in process and change management initiatives that allow for the organization to meet regulatory expectations and currently maintains mentorship to Pharmaceutical personnel within and external to her affiliated organization.

JOHN SOLOMON

Head of Pharmacovigilance-UK & Ireland

Sanofi

John Solomon is the UK/IE MCO Head of Pharmacovigilance responsible for leading the post authorisation drug surveillance activities for the broad Sanofi portfolio including Innovative, Generics, Biologics and Vaccines products.

Prior to joining Sanofi in 2005 John was the Head of Drug Safety Europe at MDS Pharma Services.Qualified in medicine, John has worked for over 16 years in the industry spending most of these years in clinical drug safety and post marketing drug surveillance activities.

Other industry related experience includes pharmaceutical marketing and global Clinical research programmes from within the Pharmaceutical industry and Clinical Research Organisation sector respectively.

John is currently a Pharmacovigilance representative on UK Pharmaceutical and Self-care industry trade associations.

John is especially committed to transparency around patient centric Pharmacovigilance and the Commercial value of effective Pharmacovigilance.

ANKA G. EHRHARDT

Director Clinical Cytometry, Biomarker Technologies, ECTR

Bristol-Myers Squibb

Dr. Anka Ehrhardt is a biophysicist with a doctorate degree in human physiology. She currently lives in the United States.

Throughout  her carrier, Dr. Ehrhardt  combined technical expertise with strategic excellence and operational savvy to build and run laboratories and teams, drive them to become Centers of Excellence and key partners, serving the discovery and development needs of large biopharmaceutical companies. Through this work, e.g. at Merck and BMS, Dr. Ehrhardt encountered the key issues in biopharma research and development, the specific challenges in different ways of clinical data collection,  in particular the needs for ongoing close communication between all partners, including patients, care givers, sites, CROs, and sponsors, emphasizing the importance of strategic planning and ongoing analysis.  Based on the observed needs, Dr. Ehrhardt lead teams of increasing size in developing and implementing strategies reaching form securing that biomarker assays are optimized to gather clear data in support of fast well founded decision making, to systematically maximizing the information gathered from clinical samples in support of hypothesis generation.

Dr. Ehrhardt is currently on the board of different industry organizations, fostering innovation and collaboration between industry, academia and government organizations.

BARBARA DA SILVA-TILLMANN

Senior Medical Director

Abbvie

MELVA T. COVINGTON

Senior Director, Health Outcomes & Value Assessment

Pacira Pharmaceuticals

GEORGE VAN BAELEN

Head Pharmacovigilance Latin America & Carribean

Shire

Georges van Baelen, M.Sc.Ph. was born in Belgium and grew up in Latin America, most notably in Brazil and Peru. He received his education in medical and pharmaceutical sciences at Medical Schools and Universities in Belgium and the United States.
Georges started his career in drug safety with the management of the OPTIME trial, the first FDA-approved placebo-controlled Phase IV trial in the Intensive Care Unit (ICU) setting, and built up his expertise in pharmacovigilance by working in both the clinical and the non-clinical environments of drug development, and product launch and marketing. He has been involved in the development of expanded access programs (EAPs), especially in Asia Pacific and Latin America, as well as the implementation and operational build-out of pharmacovigilance systems in emerging economies such as Brazil, Colombia and in developed countries such as Germany and Australia. He is co-author of a reference work on Global Medical Information Regulations.
Georges was until recently the Regional Head for Pharmacovigilance – Latin America/Caribbean at Baxalta/Shire. He currently divides his time between independent consulting in and writing about Medical Information practices and regulations throughout Latin America.

NAMRATA SINGH

Director

Turacoz Healthcare Solutions (India)

CLAYTON DEHN

Senior Vice President, Early Phase Services & Strategic Development

Clinical Trials of Texas

Clayton Dehn is a clinical research physiologist with particular expertise in endocrine disorders, especially those related to fertility and metabolic disturbances. He is a co-inventor of a process and substance for disturbing the inheritance pattern of ion-channelopathic disorders by selectively disabling genetically undesirable sperm cells. He is also the sole author of the first publication cautioning against the risk of SGLT-inhibition inducing ketoacidosis in insulinopenic populations. He has served by gubernatorial appointment to the Arizona Biomedical Research Commission and continues to serve on the editorial board of four peer-reviewed journals.

MARTIN H. BLUTH

Chief Medical Officer

Consolidated Laboratory Management Systems (CLMS)

Dr. Bluth completed his MD and PhD (Immunology) degrees at SUNY Downstate Medical Center, residency in Clinical Pathology at Kings County Hospital, his fellowship training in Transfusion Medicine at the New York Blood Center and post-doctoral fellowship in tumor markers at the Veteran’s Affairs Medical Center in NY. He maintains board certification in his disciplines. He currently serves as Chief Medical Officer for Consolidated Laboratory Management Systems, holds an appointment as Professor of Pathology at Wayne State University School of Medicine, Medical Director of Pathology Laboratories for Michigan Surgical Hospital and National Medical Director for Kids Kicking Cancer. He also serves as Associate Editor for Henry’s Clinical Diagnosis and Management by Laboratory Methods, the premier textbook on Clinical Pathology and Laboratory Medicine, serves as Editor in Chief for four peer reviewed medical journals, and reviews for over a dozen other journals in various disciplines. He is a serial entrepreneur in maturing novel biomarkers as well as devices and therapeutics (www.bluthbio.com), serves on numerous committees including the Michigan State Medical Society Committee on Health Care Quality, Efficiency and Economics, is considered an expert in his field, has authored over 250 publications, and is sought after for speaking engagements worldwide.

SHEILA WEISS

Senior Research Leader

Evidera

Sheila Weiss, PhD, FISPE, is Senior Research Leader, Drug Safety, at Evidera. With 20 years of experience in Pharmacoepidemiology and Regulatory Sciences, Dr. Weiss has worked in all sectors - academic, government, and industry - within Life Sciences. At Evidera she works on epidemiology research, risk evaluation and management programs, and other safety-related projects as a principal investigator or advisor. Sheila also serves as a consultant, working with clients on complex safety issues, regulatory milestones, and overall safety strategies for drugs and other regulated medical products.
Prior to joining Evidera, Dr. Weiss was Professor, and founding Director of the Center for Drug Safety, at University of Maryland Schools of Pharmacy and Medicine and Visiting Professor at Johns Hopkins University. Dr. Weiss has published approximately 50 scientific papers and given over 100 presentations. She has worked as an advisor and/or employee at a number of Federal agencies including FDA, NIH, and VA.
Sheila Weiss has a Ph.D. in Epidemiology from the Johns Hopkins University and completed a postdoctoral fellowship in Pharmacoepidemiology & Regulatory Sciences at the US Food and Drug Administration. Dr. Weiss is a Fellow of the International Society of Pharmacoepidemiology.

SHEETAL KHEDKAR

Senior Director, Regulatory Science

Sarah Cannon Development Innovations

  • Medical professional with over 10 years of CRO, pharma and academia experience in phase I-IV Oncology (solid and hematological malignancies) clinical research
  • Holds leadership positions in developing and maintaining highly effective collaborative relationships with key stakeholders (CRO, pharma and site)
  • Drive business growth by improving customer loyalty through enhanced customer relations, service delivery excellence and excellent customer communication.
  • Lead development of safety profile of a molecule with pharmaceutical Sponsor, including development of core product risk log (CPRL), signal detection, and maintenance of global product safety database
  • Subject matter expert in Pharmacovigilance requirements for Clinical trials in the USA, Canada and Europe, working knowledge for Asia-Pac
  • Lead and contributed to Global initiatives in safety, medical writing and regulatory operations for global business expansion
  • Alliance lead for CRO collaborations in Europe and Asia-Pac
  • Actively participated in multiple IND and CTA submissions Lead protocol development and proof of concept Phase II-IV on multidisciplinary teams
  • Author for the Pharmacovigilance Module of Joint Alliance Duke-NUS Education Certification Programme in Medical Affairs

ROBERT S. WALSH

Consultant

Walsh Medical Consulting

"Rob Walsh is a cardiothoracic surgeon with over 20 years clinical experience and over 10 years experience in industry. He practiced both in academia and private practice. He has worked at Boston Scientific, Hospira and AbbVie in Medical Affairs, Clinical Development and Pharmacovigilance and Patient Safety.  He currently is a consultant to the industry through Walsh Medical Consulting."

ORGANISED BY

Virtue Insight

Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.

Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.

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Explara

Event Brite

Pharma Phorum

Pharmaphorum is the primary facilitator of thought leadership and innovation within pharma. We support the next generation of pharmaceutical industry leaders through producing, curating and publishing media that will help pharma embrace the challenges of being a healthcare solutions provider in the 21st century.

Our services include:

  • Publication of interesting new written, audio and video content addressing critical pharma issues from around the world.
  • Showcasing key service providers who can work with pharma executives to forge the business models of the future.
  • Curation of global news, industry events and job opportunities within pharma.
  • Production of written, audio and video content for publication on pharmaphorum or client channels.
  • Advice and support on the use of social media within pharma to effectively connect companies, improve PR and share innovation.

Going To Meet

Conference Locate

Clocate.com is a leading international directory for worldwide conferences and exhibitions. Clocate.com is equipped with a unique and comprehensive search that helps you find easily any event in any category or location.  Each event includes detailed information, like, description, dates, location, map, prices, link to the official event's  website and more...

If you search for a conference or exhibition in areas such as Industry and manufacturing, Health and medicine, Technology and IT, Business and finance, sciences, education, services (banking, insurance, tourism, Hospitality and more), government, environment, life style and arts, you'll find it in Clocate.com

Crowd Reviews

https://www.crowdreviews.com/best-medical-lab-software

 

CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users which have experienced products and services first-hand and have an interest in letting other potential buyers their thoughts on their experience. CrowdReviews.com is driven by an algorithm allowing for both customers and providers of products and services to understand how the rankings are determined. The service can be used by potential buyers to learn more about their vendors prior to making a purchasing decision.

Technology Networks

Pharmaceutical-review

Pharmaceutical-review.com is a global B2B platform serves for complete Pharma industry. It currently lists million of companies, namely manufacturers, service providers, wholesalers and distributors. Every month more than 100,000 unique visitors come to the Pharmaceutical-review.com site through search and our subscriber database.

Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world. Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-newsletters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.

Nanobay

Nanobay.com is an online platform dedicated to micro-and nanotechnology products, services, research, investment, news and events. Nanobay’s visitors are scientists, researchers, business people, government, academia, and enthusiasts. Nanobay.com offers a stage for international visibility and provides services including answers on technical questions or finding the right partners, suppliers, products or technology for companies or institutes. Register for free under

SupplyChainBrain

SupplyChainBrain, the world’s most comprehensive supply chain management information resource, is accessed year round through a wide range of ever evolving multi-media formats by hundreds of thousands of senior level industry executives. In addition to addressing the fundamental principles of supply-chain management, SupplyChainBrain identifies emerging trends, technologies and best practices, forward thinking ideas and cutting-edge solutions-and continues to write and report about these as they evolve and mature.

LIMSfinder

Welcome to LIMSfinder, the most comprehensive online, interactive magazine devoted to Laboratory Information Management Systems (LIMS) and other Laboratory Informatics Solutions. LIMSfinder is simply the best resource for Information Technology in the Laboratory.

ManuscriptEdit

Manuscriptedit.com, your online partner for Scientific & academic paper English language editing, proofreading, medical writing, formatting, design & development and journal publication support services.

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Partnering with Virtue Insight means more than making the right contacts. It means being an insider. It means being connected to the right people with the right level of influence, and it means you are allied with a globally respected organization and leaders in the industry.?


Sponsorship, exhibiting and advertising packages are designed to provide a solid platform to help you stand out and make an impact. Our programs allow you to achieve your marketing goals and deliver a maximum return on your investment. We have developed convenient and customizable packages to help your organization meet its objectives and reach your target market.


Why Sponsor / Exhibit:

PROFIT: To Maximize
MARKET SHARE: Defending and Increasing Market Share
COMPETITION: To attach and defend against competition


Benefits:

  • Generating sales leads
  • Build brand image
  • Maintaining customer relations
  • Consolidating business relationships
  • Accessing new and emerging markets
  • Obtaining technical knowledge
  • Leverages the events extensive marketing campaign to add value to your organisations marketing strategy and budget leading up to the event
  • Live product demonstration to test market responses
  • Facilitating quick market penetration
  • Reach important targeted commercial prospects face to face in a social, relaxed environment. The ideal platform to build strong business friendships Strengthen your market position


Our conferences offer not only a unique combination of benefits (as listed above) to enable the sponsor/exhibitor to communicate the message but also a major opportunity that other forms of selling or media cannot provide.


Contact Us Today

UK
Email - sponsor.uk@virtueinsight.com
Tel: +44-2036120886


INDIA
Email - sponsor@virtueinsight.com
Tel: +91 44 64536444


Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.


What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.


What are the benefits of attending?

  • Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
  • Enjoy our informal networking at drinks and lunch
  • Meet the leading solution providers in the market to forge partnerships and discover solutions
  • Receive electronic versions of the conference documentation for use of reference post-event.
  • Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
  • Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
  • Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
  • Delegates also benefit from discounted rates onfuture event attendance


For more information or to register at the event please contact us TODAY:


Contact Us Today

UK
Email - delegate.uk@virtueinsight.com
Tel: +44-2036120886


INDIA
Email - delegate@virtueinsight.com
Tel: +91 44 64536444

Introductory Offer (3 delegate places for the price of 2):- A huge saving of £1100 - (Limited seats left) - You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com 

 

Standard Registration:- Conference Delegate Pass (£1100 per delegate) – You can simply email or call and book your conference delegate seats on – TEL: +44 2036120886. Email – delegate.uk@virtueinsight.com 

 

Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to – TEL: +44 2036120886. Email – sponsor.uk@virtueinsight.com

Holiday Inn Chicago O’Hare

Address: 5615 N Cumberland Ave, Chicago, IL 60631, USA
Phone:+1 773-693-5800

Testimonials from our past Pharmacovigilance Conferences

 

 

Good efforts, well organised, experienced speakers, current and concrete topics. Promises delivered – Pharmacovigilance Manager, Cheplapharm Arzneimittel GmbH

A lot of interesting topics – Global Compliance and Quality Director, Kantar Health

Well organised, Thank you – Senior DSA, Covance CAPS

The content of the conference is always good. Good to see speakers from regulatory authorities. Always delighted to attend your conference Medical Services, Cipla

Conference was very informative & added much knowledge about Pharmacovigilance systems, ADE, process flow of reporting, searching data & mobile networking Asst. Manager Regulatory Affairs, Emcure Pharmaceuticals

Well arranged and good interactive crowd AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research

Yes, it is good platform to understand the current industrial practice & the thought process Assistant Manager, Clinical Research & Pharmacovigilance, Bharat Serums And Vaccines

Very good coverage of the area of PV Safety Physician, Sciformix Technologies

It was a good learning experience Team Leader, Cognizant Technology Solutions

Good platform to know about peers in the industry and for knowledge sharing Pharmacovigilance Associate, Quanticate

Over all the conference was helpful Senior Director - Clinical, Aris Global Software

This kind of conference is very important for younger generations and professionals to get mere awareness and day to day updates in markets CIO, Qtech Solutions

A commercial knowledge venture explored several areas under the topic. Very good and Professional speakers. Over all more than satisfaction Director, SYNORBS BIOSOLUTIONS

Panel discussions are very interactive as well as address real world and practical issues Head – Medical Affairs, Wockhardt

I deeply appreciate the way you have organised the 11th Pharmacovigilance 2016. I would like to congratulate the whole team of virtue Insight for successfully organizing this meet. I am delighted to have participated in the meet, I had the opportunity to interact with field experts and totally i had a wonderful experience being their. Your team work was well established and everything was in place. The way you have organised the lectures and discussion on the floor is deeply appreciated. My Best wishes to the whole team of Virtue Insights Director, SYNORBS BIOSOLUTIONS

The 9th Pharmacovigilance 2015 conference was a very thought provoking day. The content of the conference was great; experienced, talented speakers and size was enough for really good conversations. I have enjoyed the whole conference. My brain was both stretched and strained – never exhausted - Senior Manager - Regulatory Operation, Medical Affairs Wockhardt Limited

Very good platform to meet other pharmacovigilance expertise and interact with them about the advances & opportunites in pharmacovigilance. Virtue Insights is really good at coordinating and organizing - Safety Physician, Sciformix

It was very good conference. Thank you very much for offering me a speaker position. Keep up the good work and all the best for future conference - Head Pharmacovigilance, Wockhardt

End to end PV process discussion would be more helpful - Medical Writer, Parexel

It was really helpful in the terms of sharing knowledge - Drug Safety Specialist, Cipla

Very well organized and the sessions were so well placed. Got enough time for networking and well time managed - Country Safety Lead, Pfizer Limited

This conference is very useful for my work. I expect that every year Virtue Insight will organized this kind of conference - Research Scientist, Alembic Pharmaceuticals Limited

“The whole session was more lively and in particular the panel discussions” - PV Lead & Deputy QPPV, Auden Mckenzie (Pharma Division)

I liked the variety of presentations - Vice President - EU QPPV, The Medicines Company

Chairman was excellent. Speakers all delivered great talk. Great discussions, exchange and brainstorming was very useful - Associate Director, Global Drug Safety & Risk Management, Celgene Europe

Very Insightful – Speakers were very knowledgable - Manager, Results healthcare

Topics deliberated on social media were a good break from usual topics at pv conferences. A good line up of speakers - Consultant, Adamas Consulting

Well thought topics, very interactive session - Principal Consultant, Adamas Consulting India

Good informative and knowledge sharing session - Manager, Ranbaxy

A very good platform where cream of the Pharmacovigilance field of Indian pharma shared their views/opinions on involving of Pharmacovigilance trends & how to improve pv in India - Business Development Associate, Techsol Systems India Pvt Ltd

Informative session focusing on new and grey areas of Pharmacovigilance patient care being the utmost priority on minds of all the pharma company new aspect discussion and light on the grey areas had open new arena for Pharmacovigilance
thank you - Drug Safety Associate, Cipla

Well organized - focused on relevant topics - excellent choice of speaker’s food for thought - Head Pharmacovigilance, BMS India

The conference was well organized Content and quality of discussion were more informative. Thank you Virtue Insight - Head Pharmacovigilance, Wockhardt

I would truly like to appreciate the efforts and initiative of Virtue Insight in organizing this PV dedicated conference. I think its one of its kind in India, where the meeting is focused only on Pharmacovigilance. Kudos to the team for the well- organised and well –planned meeting. Its one event resulting in the confluence of PV personnel, networking and exchange of knowledge. Keep up the good work. Thanks and good luck - Head - Pharmacovigilance, Bristol-Myers Squibb

The panel discussions did truly impart knowledge - Deputy DSR, Novartis

This conference was very good for the pharmacovigilance professionals as well as business people. Organising this event and the event management was nicely done by Virtue Insight - IT Administrator, Oviya Med Safe Pvt. Ltd

The conference was interesting and was a good platform for networking. The audience and the panelists were from varying backgrounds giving an insight to various challenges being faced by the Indian industry - Manager- BD, ELC Research

Virtue Insight has established a niche for iteslf in the world of pharmacovigilance events held in India. The progressively increasing attendance from all stakeholders of Drug safety serves as a testimony to this - MD &
CEO, Oviya Med Safe Pvt. Ltd

Good insight into Indian Pharmacovigilance scenario. This should happen regularly to keep the concerned updated - Team Manager, Cognizant Technical Solutions

The conference here was a good platform for discussing pharmacovigilance challenges in India and knowledge sharing with respect to pharmacovigilance - Officer Global PV, Sun Magma

Conference on pharmacovigilance was very specific to the subject and was managed well in terms of sessions held throughout the day - Associate Director, PV Delivery, Sciformix

It was indeed a rich learning experience. Hope it will continue in the future - Gayathri Subramani, Pharmacovigilance Associate, Oviya Med Safe The overall conference was informative. 3rd Annual Conference has actually started addressing the practical, day to day issues coming in the way of industrial PV solutions are disscussed - Regulatory Affeirs, Inventia Healthcare

Very nice conference - Executive - Medical Affairs, Johnson & Johnson

A well-organized conference that provides value for money not only the session, but the networker opportunities provides were very useful for building companies like Oviya Med Safe - Founder & CEO, Oviya Med Safe

The conference was very informative - Sr. CRA, Clininvent Research Pvt . Ltd

Very well organised Conference with speakers having appropriate expertise and adequate enthusiasm to dissipate acquired knowledge - President R&D, FDC Ltd

The Conference was a good platform for getting views about Pharmacovigilance practices across pharma companies - Asst. Manager - Medical Affairs, Wockhardt

Very enlightening subject specific. Good mix of delegates from industry and academics - Senior Executive - Clinical Research, Wockhardt

Worth Attending ! Loved the experience! - MSC Clinical Research, ICRI - Ahmedabad

Very Informative sessions - CSO, Boehringer Ingelheim

The Panel Discussion were highly informative and Interesting. It was great learning experience & foundation for organisation who are in the process of setting up their PV systems. We look forward for more such support - Senior Manager - Regulatory Affairs, Inventia Health Care

"The conference was indeed a great experience.Both the presentations and the panel discussions/interactive sessions were very enlightening.I would surely like to attend the  May clinical trial conference. I congratulate Virtue Insight for organizing a very useful and interesting Conference." - Medical Department, Elder Pharmaceuticals

“PV 2010 was an opportunity to identify future clients as well as competitors along with an excellent learning platform” - Pharmaceutical Professional, Ecronacunova

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