28th Pharmacovigilance 2022
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WHY SHOULD YOU ATTEND?
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 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.
Event Speakers
KHAUDEJA BANO
Amgen
KHAUDEJA BANO
Amgen
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
MICHAEL FRIES
CSL Behring
MICHAEL FRIES
CSL Behring
MICHAEL FRIES, Head, Biostatistics, CSL Behring
Michael Fries is the head of Biostatistics at CSL Behring. Michael earned his Ph.D. from the State University of New York at Buffalo and has over 20+ years of biostatistics drug development experience from non/pre-clinical to phase 4 with more than ten years in leadership positions. Michael was first involved in specific statistical questions in safety when he helped establish the PSAP process in GSK. He then joined the American Statistical Association Biopharmaceutical Safety Working Group, where he has primarily participated in the Bayesian Methods area and supported work on developing the ASAP.
JIM BUCHANAN
Covilance
JIM BUCHANAN
Covilance
JIM BUCHANAN, President, Covilance
Dr. James Buchanan is presently an independent drug safety consultant. He graduated from the University of California, San Francisco with a PharmD degree in clinical pharmacy. He worked in the area of clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General Hospital before entering the pharmaceutical industry. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety in the clinical development department. He subsequently moved to Gilead Sciences to establish a drug safety department. After leaving Gilead Sciences, Dr. Buchanan started the drug safety department at Tularik Inc where he acted as Chief Safety Officer until the company was acquired 5 years later by Amgen. Following the merger with Amgen, he moved to Nuvelo to establish a drug safety department and act as Chief Safety Officer where he also had responsibility for clinical operations, biostatistics and data management. Dr. Buchanan next served with BioSoteria for 5 years as the head of the medical and safety consulting group, which was subsequently acquired by Dohmen Life Science Services. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group and is a co-lead on the Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development.
BRIAN DREYFUS
Bristol-Myers Squibb
BRIAN DREYFUS
Bristol-Myers Squibb
BRIAN DREYFUS, Senior Director -Solid Tumor Oncology Epidemiology, Bristol-Myers Squibb
ELENA YURENEVA
Alnylam Pharmaceuticals
ELENA YURENEVA
Alnylam Pharmaceuticals
ELENA YURENEVA, Executive Director, Head of Medical Safety and Risk Management, Alnylam Pharmaceuticals
Elena Yureneva, MD, MHA currently serves as an Executive Director at Alnylam Global Patient Safety and Risk Management department, Head of Medical Safety and Risk Management. Dr. Yureneva acquired her MD at the First Moscow State Medical University in Russia and specialized in cardiology. She acquired her Master’s Degree in Health Systems Administration at Georgetown University. Prior to pursuing her career in pharmaceutical industry, she served as a Chief of Staff to the Chief Medical Officer at Children’s National Health Systems in Washington, DC. Dr Yureneva has 9 years of pharmacovigilance experience from Alnylam, Merck and Cubist.
AJINKYA I
Janssen Pharmaceuticals
AJINKYA I
Janssen Pharmaceuticals
AJINKYA INAMDAR, Director, Global Medical Safety, Global Safety Strategy and Risk Management, Janssen Pharmaceuticals
NANCY DUBOIS
Merck-EMD Serono
NANCY DUBOIS
Merck-EMD Serono
NANCY DUBOIS, Head of Global Drug, Safety, United States Region, Merck-EMD Serono
SHARON REID
Pfizer
SHARON REID
Pfizer
SHARON REID, Director, Risk Management Product Lead, Pfizer
TEODORA D
Janssen R & D
TEODORA D
Janssen R & D
TEODORA DOHERTY, Global Medical Safety (GMS), Medical Safety Officer, Janssen Research & Development
FATIMA G
KAMC (Saudi Arabia)
FATIMA G
KAMC (Saudi Arabia)
FATIMA GHETHAN, Head of Quality and Medication Safety Department, King Abdullah Medical City (KAMC) – MAKKAH (Saudi Arabia)
HUMAIRA Q
Synowledge
HUMAIRA Q
Synowledge
HUMAIRA QURESHI, CEO, Synowledge
With more than 20 years experience in Pharmacovigilance, Humaira brings a wealth knowledge to her valued customers and team. She has held various leadership roles with ever increasing responsibilities, most recently as CEO of Drug Safety Solutions. Her results driven skills focuses on strategies for clients, addressing their business and operational challenges.
KAL ELHOREGY
Amneal Pharmaceuticals
KAL ELHOREGY
Amneal Pharmaceuticals
KAL ELHOREGY, Director, Risk Evaluation and Mitigation Strategy (REMS) Programs, Amneal Pharmaceuticals
Kal Elhoregy is an accomplished healthcare industry executive with 24+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems (QMS) and Pharmacovigilance (PV) Compliance within the pharmaceutical industry. In his current role as a Director, Risk Evaluation and Mitigation Strategy (REMS), Regulatory Affairs Clinical at Amneal Pharmaceuticals, he manages all risk management programs and ensures the entity’s full compliance with risk management standards and guidelines.
As a strategist and accessible leader with experience in PV & Quality Risk Management (QRM), he helped multiple disciplines to effectively manage compliance risk in accordance with regulatory guidelines and increasing organizational capacity through streamlining complex processes.
He is a registered and licensed Pharmacist and holds a Bachelor of Science, Accounting from the Faculty of Commerce, Ain Shams University and Bachelor of Science of Pharmacy from Arnold & Marie Schwartz College of Pharmacy, Long Island University, New York.
His experience within the Health Care settings as a lead infusion Pharmacist, including Pediatric Intensive Care Units and Critical Care Unit Pharmacies. Also, his experience within the Pharmaceutical industry includes a strong expertise and leadership in PV Compliance, QRM and Quality System of PV, REMS, Risk Management Plan (RMP), GVP / CSV Risk Based Audit and Inspection Readiness.
Kal believes in leadership and teamwork and focuses on what is important to achieve successful results in ensuring patient safety and regulatory compliance.
KAPIL BHUTADA
Medicago
KAPIL BHUTADA
Medicago
KAPIL BHUTADA, Director, Pharmacovigilance Compliance and Training, Medicago
MOHAMMED B A
Ionis Pharmaceuticals
MOHAMMED B A
Ionis Pharmaceuticals
MOHAMMED BASEER AHMED,Executive Director, Drug Safety, Ionis Pharmaceuticals
AYSE BAKER
Almatica (Alvogen)
AYSE BAKER
Almatica (Alvogen)
AYSE BAKER, Vice President of Regulatory Affairs, Almatica (Alvogen)
BILL HADDOCK
Ovid Therapeutics
BILL HADDOCK
Ovid Therapeutics
BILL HADDOCK, Head of Safety, Ovid Therapeutics
TARAK THAKKER
BeiGene
TARAK THAKKER
BeiGene
TARAK THAKKER, Director, Safety Systems, BeiGene
- Tarak brings around 20 years of Life Sciences and Pharmacovigilance experience and have spent his time solving critical problems for PV industry through technology use cases
- Tarak has been part of identifying and solving multiple use cases through AI and automation for case intake and processing
- Tarak has been a regular speaker at conferences and have delivered an educational seminar at DIA on AI/ML in PV
- Prior to joining BeiGene, Tarak was leading global implementations of automated Intake and Safety System at RxLogix, has been involved with IBM Watson (AI based Platform) to solve PV use cases and have worked with Deloitte, Oracle/Relsys and Otsuka
- In his free time Tarak enjoys sports and travelling
SUTAPA M
Deciphera Pharmaceuticals
SUTAPA M
Deciphera Pharmaceuticals
SUTAPA MUKHOPADHYAY, Director, Pharmacovigilance Operations, Deciphera Pharmaceuticals
Sutapa Mukhopadhyay is an enthusiastic, results-oriented Pharmacovigilance professional. A Ph.D. with post-doctoral, Sutapa commenced her career in academics and taught Human Physiology to undergraduate and graduate Pharmacy students. During the period, Sutapa inspired and touched lives of many and established deep connections with her students that has lasted for decades. A true believer in challenges as her opportunities for growth, Sutapa changed courses and joined the industry. Recognized for leading large operations teams through inspirational and disciplined management, Sutapa has led critical functions, both within and outside her core areas of expertise with a passion for excellence and time-bound, high-quality outcome.
In her current role as Director of PV Operations at Deciphera Pharmaceuticals, Sutapa and her team has successfully established global PV processes across multiple territories and made meaningful contributions to the companies goals.
In her personal space, Sutapa is an ardent thespian who performs in community plays and recitations
Below is my LinkedIn & FB ID:
https://www.linkedin.com/in/sutapa-mukhopadhyay-ph-d-02810523/
https://www.facebook.com/sutapa.rumu
NIBHA MISHRA
Takeda Pharmaceuticals
NIBHA MISHRA
Takeda Pharmaceuticals
NIBHA MISHRA, Senior Scientist, Investigative Toxicology, Takeda Pharmaceuticals
Nibha Mishra works as Senior Scientists and co-chairs the global Neuro-TOS group at Takeda Pharmaceuticals. Where she supports several drug discovery programs. When she is not doing neuroscience, she is analyzing new modalities adverse events data. Before joining Takeda, she was a Researcher at Mass General Hospital where her work was focused on finding novel cure for ALS disease using CRISPR technology. She received her Postdoctoral training on brain specific microRNAs from Hebrew University of Jerusalem, Israel. She has several publications in the peer reviewed journals. During her trainings she also won several fellowships and awards.
Experience:
Takeda Pharmaceuticals
Senior Scientist, Toxicologist 2021-current
Scientist II, Toxicologist 2020-2021
Contributions: Successfully contributed to the evaluation of safety profile of several projects (from CS stage to clinical stage). Developed several assays for screening neurotoxicity profile of compounds. Developed dashboard for adverse events analysis of cell, gene and oligonucleotide therapies.
Co-chair: Global Neurotoxicity Group
Membership: HESI, MIT consortium
Mass General Hospital 2017- 2019
Postdoctoral Fellow (Advisor: Dr.Lagier-Tourenne)
Research areas: Identifying novel therapeutic targets for ALS disease by employing CRISPR screen technology and ALS patient’s cells.
Hebrew University of Jerusalem 2013-2016
Postdoctoral Fellow (Advisor: Prof. Hermona Soreq)
Research areas:Finding novel brain specific miRNA and validating their mRNA targets using miRNAand mRNA-sequencing methods.
Birla Institute of Technology 2006-2013
Lectureship (2006 -2013) while with doing PhD (2009-2013)
(Advisor: Prof. DinakarSasmal)
Research Areas: Studies on enzyme inhibitors identified through computational and pharmacological approaches against Alzheimer’s disease (AD).
Awards
Winner of the SAC 2019 Poster of Distinction Award at Mass General Hospital, Boston, USA.
Best Poster of Distinction award at Post Doc Day in 2019 at Mass General Hospital, Boston, USA.
NIRJHAR C
Takeda
NIRJHAR C
Takeda
NIRJHAR CHATTERJEE, Medical Director Pharmacovigilance, Medical Safety Rare Genetics and Hematology & PDT, Takeda
MARCIN VON G
Takeda Pharmaceuticals
MARCIN VON G
Takeda Pharmaceuticals
MARCIN VON GROTTHUSS, Principal Scientist, Investigative Toxicology, Takeda Pharmaceuticals
Principal Scientist in Investigative Toxicology with 20 years of experience executing multidisciplinary translational projects, including 8 years contribution to pioneering research on the analysis of clinical, molecular, and genomic data for drug development and safety evaluation for rare and common diseases, and precision medicine applications, initially, at The Broad Institute of MIT and Harvard and, currently, at Takeda Pharmaceuticals. Marcin von Grotthuss received a Ph.D. in bioinformatics at Radboud University Nijmegen, Netherlands, and gained professional experiences at Sanford-Burnham Institute (La Jolla), University of Washington (Seattle), Harvard University, University of Cambridge (UK), University of California Irvine, and the Brigham and Women’s Hospital / Harvard Medical School.
JERRY K. K
Ascension Wisconsin Research Institute
JERRY K. K
Ascension Wisconsin Research Institute
JERRY K. KOUNGA, Investigational Drug Lead Clinical Research Pharmacist, Ascension Wisconsin Research Institute
Jerry K. Kounga is currently the Investigational Drug Lead Clinical Research Pharmacist at Ascension Wisconsin Research Institute where he brought over 30 years of experience as a clinical researcher and a bench scientist. He earned his master’s degree in Biochemistry at the Faculty of Sciences and Pasteur Institute in Yaoundé-Cameroon. His work led to the first colorimetric assay to determine the lethal concentration of drugs during the treatment of Chloroquine-resistant Malaria. He received a scholarship from the Kansas Cancer Foundation and completed his PhD in Biochemistry from the University of Kansas in Lawrence, working with Prof. Richard Himes. His thesis work elucidated the complex mechanism by which Leucovorin rescues normal cells during chemotherapy with high regiments of Methotrexate and highlighted the importance of folates pathways in cancer patients’ recovery.
After completing his PhD, he accepted a postdoctoral position as a member of the Cutaneous Biology Research Center in the Department of Dermatology at Harvard Medical School in Boston, MA, where he worked for eight years. He isolated a new potent vasodilator peptide and purified a new itch/pruritus causing molecule, both used to probe novel treatment of human thromboembolic stroke and elucidate the pruritus mechanism in humans, respectively. He furthered the work on the molecular mechanism of natural and actinic aging processes by using transgenic animal models to probe the basis of hairs-graying in humans.
During his years at Harvard, he became very passionate about clinical pharmacology and ethnic skin biology. He completed a PharmD from the Massachusetts College of Pharmacy and Health Sciences in Worcester, MA. After exploring the various facets of pharmacy practice, including retail, long-term care, infusion pharmacy, and inpatient/ER hospital pharmacies, he realized the value of pharmacists as critical players within the healthcare ecosystem.
While at Harvard, Jerry collaborated with Dr. Eliot Battle Jr to formulate effective ethnic skin personal care products using unique ethnic skin features as a guide. To further that initiative, he accepted the Director of research and Development position at Cultura Dermatology and Laser Center in Washington DC, where the two reunited and strived for their shared goal of better ethnic skin care. They teamed with the Australian SNIPs-based SkinDNA to bring this novel skincare approach to the US and were the founding members of Targeted DNA, the USA version of SkinDNA. Jerry also harnessed his comprehensive knowledge in ethnic skin biology to identify effective botanical ingredients for various ethnic skin conditions and created a combinatorial algorithm for personal skin care formulation based on individual skin DNA SNPs analysis. He recently deepened his clinical research knowledge through completing the well-tailored Drug Safety and Pharmacovigilance Certification at Sollers College, NJ, Pharmacogenomic Certification by ASHP, and publishing the first Universal Urgent Care and Forensic Passport that is being translated into different languages for worldwide vulgarization.
Jerry recently joined the ascension Health Wisconsin ministry in Milwaukee, Wi, where his impact on clinical research filters throughout the organization. His current advocacy work focuses on using preemptive pharmacogenomics as the base for precision personalized/medicine and implementing mandated adverse drug reaction reporting as the new approach for robust global pharmacovigilance. His core involvements are a testament to his loyalty and quest to improve patient and drug safety in clinical practice throughout the continuum of care and help healthcare providers stay abreast of new and innovative medical procedures worldwide.
KATARINA ILIC
Takeda Pharmaceuticals
KATARINA ILIC
Takeda Pharmaceuticals
KATARINA ILIC, Senior Medical Director, Clinical Science, Rare, Genetics and Hematology TAU, Takeda Pharmaceuticals
HEMANG M
Servier Pharmaceuticals
HEMANG M
Servier Pharmaceuticals
HEMANG MAISURIA, Director, Global Safety Lead, Servier Pharmaceuticals
“Dr. Hemang Maisuria is a seasoned professional with over 25 years of experience within the pharmaceutical arena. In addition to his clinical background, he has also completed his JD in Health Law and Intellectual Property. He is currently serving as a Director and Global Safety Lead for Servier Pharmaceuticals; responsible for their lead IDH1 inhibitor product Tibsovo. He oversees the benefit / risk portfolio of the product as well as the strategic management of the product lifecycle. He previously managed this product at Agios Pharmaceuticals, and was transitioned to Servier following the acquisition of the asset by Servier last year. Prior to joining Agios, he was the Director of Drug Safety / Pharmacovigilance and Risk Management at Amneal Pharmaceuticals. In this capacity he was responsible for global pharmacovigilance activities including Labeling, REMS, Medical Information, and Analytics for Amneal.
Dr. Maisuria has extensive CRO experience as well, having led the establishment and growth of the first US based full service pharmacovigilance provider; inclusive of technology, processes and personnel, called Sentrx. In his role as VP of Commercial Development, he has engaged with industry leaders and provided his expertise in establishing full PV capabilities for over 50+ large and small pharma companies.
Dr. Maisuria has also served as an Adjunct Professor at LIU and Rutgers University in their pharmacy programs, and as a mentor for his students during their academic career and beyond.”
BEN LOCWIN
Black Diamond Networks
BEN LOCWIN
Black Diamond Networks
BEN LOCWIN, Executive SME, Black Diamond Networks
JESSICA VAUGHN
Wiley Rein
JESSICA VAUGHN
Wiley Rein
JESSICA VAUGHN, Attorney at Law, Wiley Rein
Jessica is an associate in Wiley’s Food & Drug practice. She provides clients with legal and regulatory support needed to design and implement regulatory strategies to advance products, including pharmaceuticals, medical devices, food products, and dietary supplements, through the premarket approval regimen of the U.S. Food and Drug Administration (FDA) and its European counterparts. She has experience in clinical trial development and review, pre-clinical testing review and protocol development, expedited program applications, and Investigational New Drug (IND) application and New Drug Application (NDA) planning, drafting, and filing.
With a doctorate in toxicology and over 10 years of experience in pharmaceuticals, Jessica brings a unique perspective to FDA and drug development issues. Prior to joining Wiley, she served as in-house counsel at a biotech company, and can provide an insider view to the issues facing pharmaceutical clients. Jessica’s scientific research experience allows her to review and advise on both early and late stage drug development issues, as well as allowing her to provide a critical eye during pharma and biotech transactional due diligence and litigation discovery activities.
ELIZABETH WB
Virginia Commonwealth University
ELIZABETH WB
Virginia Commonwealth University
ELIZABETH WHITE BAKER, Associate Professor, Virginia Commonwealth University
LYNN MEHLER
Hogan Lovells
LYNN MEHLER
Hogan Lovells
LYNN MEHLER, Partner, Hogan Lovells
Lynn Whipkey Mehler is a partner in Hogan Lovell’s Washington, DC office. She is the head of the firm’s Pharmaceuticals and Biotechnology regulatory practice and Co-Head of the global Life Sciences & Health Care industry sector. Drawing on her 12 years with the FDA’s Office of the Chief Counsel, Lynn has a deep understanding of the FDA and advises clients on a range of FDA and DEA regulatory matters. She has worked extensively on the approval processes for new drugs and biologics; on safety issues, including pharmacovigilance and Risk Evaluation and Mitigation Strategies (REMS), and on unique regulatory issues raised during the development and marketing of controlled substances.
“Latest developments in pharmacovigilance, drug safety & risk management”
Event Schedule
Meet and to network with your conference colleagues.
28th Pharmacovigilance 2022 – day 1
15th June
28th Pharmacovigilance 2022 – day 2
16th June
09:30 – Welcome address and Chairperson opening remarks
BEN LOCWIN, Executive SME, Black Diamond Networks
MARKET TRENDS & WAY FORWARD
09:40 – Development of successful safety teams for optimized signal detection and management
ELENA YURENEVA, Executive Director, Head of Medical Safety and Risk Management, Alnylam Pharmaceuticals
10:20 – Algorithm based approach to Phase 1 risk management/stopping rules and adverse reactions
- Key aspects to consider
- Anticipated effects based on mechanism of action
- Trial design: Single Ascending Dose and Multiple Ascending Dose
- Regulatory requirements
BILL HADDOCK, Head of Safety, Ovid Therapeutics
11:00 – Morning Coffee/Tea & Discussion
11:20 – Keynote Panel Discussion: Optimising the PV ecosystem for betterment
- Pharmacovigilance in the US: What comes next for the industry?
- Impacts of pandemic over PV – Areas for improvisations
- Outsourcing in PV especially during this pandemic – Best Practices, Challenges and key consideration in choosing right vendor
- How global PV impacts day to day operations?
- New ways to generate evidence including real world evidence
- Importance of proper communication – Sponsor – Site – CRO & Patients
- Best practices and lessons learnt from the pandemic
Moderator:
BEN LOCWIN, Executive SME, Black Diamond Networks
Panellists:
HUMAIRA QURESHI CEO, Synowledge
HEMANG MAISURIA, Director, Global Safety Lead, Servier Pharmaceuticals
TARAK THAKKER, Director, Safety Systems, BeiGene
12:10 – Outsourcing pharmacovigilance Post Covid
HUMAIRA QURESHI, CEO, Synowledge
12:30 – Networking luncheon
QUALITY – SAFETY – SIGNAL DETECTION
13:30 – Panel Discussion – Quality, Safety & Signal Detection – What is the way forward?
- Prioritizing drug safety
- A hybrid approach to signal detection and management
- Implementing signal detection in RWD: the necessary steps.
- Strategies for best practice in Signal Detection
- How should we approach?
- Safety Signalling and Evaluation: Practical Considerations and tools
- Latest updates and hot topics
Moderator:
BEN LOCWIN, Executive SME, Black Diamond Networks
Panellists:
TEODORA DOHERTY, Global Medical Safety (GMS), Medical Safety Officer, Janssen Research & Development
FATIMA GHETHAN, Head of Quality and Medication Safety Department, King Abdullah Medical City (KAMC) – MAKKAH (Saudi Arabia)
JIM BUCHANAN, President, Covilance
14:20 – Quantitative Drug Safety and Benefit Risk Evaluation: Practical and Cross-Disciplinary Approaches
MICHAEL FRIES, Head, Biostatistics, CSL Behring
JIM BUCHANAN, President, Covilance
15:20 – Afternoon Tea/Coffee
15:40 – Operationalizing PV: Small & Big Pharma
- Rigor & Structure
- US Vs global requirements
- Launch readiness
- Embracing changes
- Establishing the required balance
SUTAPA MUKHOPADHYAY, Director, Pharmacovigilance Operations, Deciphera Pharmaceuticals
16:20 – Safety-Radar: toxicity awareness and warning systems. Towards autonomous reasoning in investigative toxicology
- Here, we present an architecture of Safety-Radar – a system for evaluating drug safety.
- The platform will support automated reasoning and serendipitous discovery of new ‘facts’ or interesting and testable hypotheses.
- We discuss the strategies of how to integrate and provide high-value AI-ready data sources an how to develop (semi) autonomous reasoning agents
MARCIN VON GROTTHUSS, Principal Scientist, Investigative Toxicology, Takeda Pharmaceuticals
16:50 – Closing remarks by chairperson
17:00 – 18.00 – Networking Drinks
09:30 – Welcome address and Chairperson opening remarks
BEN LOCWIN, Executive SME, Black Diamond Networks
09:40 – Pharmacovigilance Operations during Pandemic
- How did the PV ops adapt to Pandemic
- What were the challenges faced by sponsor and service providers
- How does the future of PV ops look like.
MOHAMMED BASEER AHMED,Executive Director, Drug Safety, Ionis Pharmaceuticals
PV FOR FUTURE
10:10 – Leveraging AI technologies to advance patient safety
- AI/NLP approaches to capturing data from free text safety forms (e.g. CIOMS) and other real world data sources such as social media and the literature.
- Using ML techniques with real world data (e.g. electronic health records and/or administrative claims) to elucidate potential predictors for AEs.
BRIAN DREYFUS, Senior Director -Solid Tumor Oncology Epidemiology, Bristol-Myers Squibb
10:40 – The landscape of Adverse events for various modalities
- Providing insights on the safety profile of newer modalities by capturing the most frequently observed serious adverse events for cell therapies, gene therapies, and oligonucleotide therapies by comparing them with small molecules therapy.
- Past 20 years trends in the safety profile of small molecule therapies and the impact of regulatory guidelines. Focusing on the area of drug-induced cardiovascular events, seizures, tumorigenicity, and hepatic disorders.
NIBHA MISHRA, Senior Scientist, Investigative Toxicology, Takeda Pharmaceuticals
11:10 – Morning Coffee/Tea & Discussion
PATIENT SAFETY
11:30 – Keynote Panel Discussion: Pharmacovigilance and Patient Safety
- Pharmacovigilance – ensuring patient safety first
- Driving patient centricity into your PV plans
- Patient Support Program in Pharmacovigilance
- A review of general issues and the specific challenges with patients
- A practical approach to reshaping patient safety
- Next generation pharmacovigilance for enhanced patient safety
- What has this pandemic thought us towards patient safety
Moderator:
BEN LOCWIN, Executive SME, Black Diamond Networks
Panellists:
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
BRIAN DREYFUS, Senior Director -Solid Tumor Oncology Epidemiology, Bristol-Myers Squibb
ELIZABETH WHITE BAKER, Associate Professor, Virginia Commonwealth University
12:10 – Updates on Combination product related observations
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
12:50 – Networking luncheon
RISK MANAGEMENT & PLANNING
13:40 – Panel Discussion – PV – Risk Management and Planning
- How does the new RMP compare with its US counterpart, the REMS?
- How effective is your risk management?
- Implementation and maintenance of RMP’s – Overcoming its challenges
- Risk management in different jurisdictions
- New approaches to managing benefit-risk
- Research and development improvement
Moderator:
BEN LOCWIN, Executive SME, Black Diamond Networks
Panellists:
SHARON REID, Director, Risk Management Product Lead, Pfizer
AJINKYA INAMDAR, Director, Global Medical Safety, Global Safety Strategy and Risk Management, Janssen Pharmaceuticals
KAL ELHOREGY, Director, Risk Evaluation and Mitigation Strategy (REMS) Programs, Amneal Pharmaceuticals
14:30 – Why pharmacovigilance sometimes fails and how to bridge the gaps?
- How does risk blindness show up in industry, by the health authorities
- It’s not my fault – case examples
- Best practices for minimizing the risks and learning from previous experiences
NANCY DUBOIS, Head of Global Drug, Safety, United States Region, Merck-EMD Serono
15:00 – Worldwide mandated adverse events reporting as new approach for effective global pharmacovigilance
JERRY K. KOUNGA, Investigational Drug Lead Clinical Research Pharmacist, Ascension Wisconsin Research Institute
15:30 – Afternoon Tea/Coffee
REGULATION OVERVIEW & UPDATE
15:50 – Key current changes and their impact on current PV
- Key current changes and their impact on current PV
- Pharmacovigilance and the role of regulatory affairs: How to achieve compliance across the business
- Future Legislation: Pharmacovigilance – Industry Vision
- PV System Legislation Updates
- Enhancing communication between regulators, regional authorities and patients
- Impact of Brexit – Regulatory aspect
- What’s next? Ways to proceed forward.
AYSE BAKER, Vice President of Regulatory Affairs, Almatica (Alvogen)
AUDITS & INSPECTIONS
16:20 – Panel Discussion – Plan, develop and implement the PV Audit Strategy Plan
- Review of FDA and EMEA requirements for risk based PV audits
- PV Audit & Inspections – Knowing what is to be done
- Develop a high-level PV audit strategy
- Real world data: are you sure you have the relevant data?
- Risk based selection criteria for auditing
- Relationship to other GxPs
- What has this pandemic thought us towards audits and inspections
Moderator:
NIRJHAR CHATTERJEE, Medical Director Pharmacovigilance, Medical Safety Rare Genetics and Hematology & PDT, Takeda
KATARINA ILIC, Senior Medical Director, Clinical Science, Rare, Genetics and Hematology TAU, Takeda Pharmaceuticals
Panellists:
KAPIL BHUTADA, Director, Pharmacovigilance Compliance and Training, Medicago
JESSICA VAUGHN, Attorney at Law, Wiley Rein
LYNN MEHLER, Partner, Hogan Lovells
17.00 – Chairperson closing remarks
17:10 – End of the conference
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Event Sponsors & Partners
We wouldn’t be able to host our conferences without help from these amazing companies.
A huge thanks to all our sponsors and partners!
Synowledge
Synowledge
Drug Safety and Pharmacovigilance Services Solutions (DSS) – Portfolio company
DSS is headquartered in the UK and has deep expertise and experience from early phase studies to marketed products. DSS has mastered collecting the reliable evidence needed to bring new drugs and therapies to market. DSS uses technology and medically qualified professionals to support clients in their current state while planning for your strategic objectives. Their PV SMEs, comprised of both physicians and scientists are end-to-end partners for our clients, proactively advising and collaborating in designing and maintaining PV services and systems which are fit-for-future.
August Research
August Research
August Research is a boutique CRO providing pharmacovigilance and clinical operations services to the global biopharmaceutical industry. From its pharmacovigilance operation in Sofia, Bulgaria, August Research provides high-quality, lower cost PV services including Safety Management Strategies, Database Hosting, Case Processing, Regulatory Reporting and Signal Detection and Assessment. August Research also provides clinical trial management services across Europe, from Phase I-IV studies working in a wide variety of indications. Visit www.augustresearch.com for more information about our services.
Virtue Insight
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Virtue Insight
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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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Testimonials
A huge thanks to all our sponsors, attendees and partners!
The Panel discussion is very informative. Sharing the expert opinion is always an insight
“},{“name”:”Pfizer”,”designation”:”Country Safety Lead UK & Ireland”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”alt”:””,”source”:”library”},”_id”:”3b8df8f”,”quote”:”
The Legal regulatory session on Day was very good. Informative
“},{“name”:”Takeda”,”designation”:”Regulatory Inspection Lead, Safety & International Global Quality”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”alt”:””,”source”:”library”},”_id”:”34ab65e”,”quote”:”
Great opportunity for networking and to learn different industry perspectives on PV systems, challenges & regulations
“},{“name”:”CSL Behring”,”designation”:”Director, Clinical Safety Physician”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”alt”:””,”source”:”library”},”_id”:”eb31001″,”quote”:”
Excellent Meeting. Thanks for the great efforts
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The Panel discussion is very informative. Sharing the expert opinion is always an insight
Biocon PV Lead
The Legal regulatory session on Day was very good. Informative
Pfizer Country Safety Lead UK & Ireland
Great opportunity for networking and to learn different industry perspectives on PV systems, challenges & regulations
Takeda Regulatory Inspection Lead, Safety & International Global Quality
Excellent Meeting. Thanks for the great efforts
CSL Behring Director, Clinical Safety Physician
Gallery
Get Involved
Speaking Opportunities
Fen Castro
fen@virtueinsight.co.in
+91 44 42108101
Sponsor / Exhibit / Delegate Bookings
Piyush Patel
piyush@virtueinsightevents.com
+44 20 3509 3779
