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WHY SHOULD YOU ATTEND?
- 40+ Speakers including Amgen, Dr. Reddy’s Laboratories, Sanofi, J&J, Takeda, Bayer, AstraZeneca, Teva, Ipsen, Shionogi, Otsuka, CSL Behring, Glenmark, Kyowa Kirin & many more
- 100+ Pharmacovigilance & Safety Experts from Pharma, Biotech, Government, Regulators & Vendors
- Global Meet – Speakers and Attendees from UK, Europe, USA & ROW
- In-Person networking: Reconnect with old faces and meet newbies as we connect face-to-face after 2 years of virtual networking
Event Speakers
KHAUDEJA B
Amgen
KHAUDEJA B
Amgen
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen (USA)
Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.
Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.
She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).
JOHN SOLOMON
Sanofi
MICHAEL BEAN
Johnson & Johnson
MICHAEL BEAN
Johnson & Johnson
MICHAEL BEAN, Senior Director, BioResearch Regulatory Compliance, Johnson & Johnson
SUMIT MUNJAL
Otsuka Pharmaceuticals
SUMIT MUNJAL
Otsuka Pharmaceuticals
SUMIT MUNJAL, Global Head of Medical Safety, Otsuka Pharmaceuticals
YVONNE N
Bayer
YVONNE N
Bayer
YVONNE NANCIU, Country Head Pharmacovigilance Deputy EU QPPV, Bayer
Medical doctor (Specialty: Clinical Genetics) with a wide clinical and laboratory expertise, holding a Masters´ degree in Pharmaceutical Medicine, and being passionate about Pharmacovigilance, Patient Safety and Engagement.
I have over 15 years of PV experience (global and local positions, clinical studies and post-marketing). Since February 2021, I am holding the position of Pharmacovigilance Country Head and German QPPV (Stufenplanbeauftragte) at Bayer in Germany. Additionally, I am a lecturer for Pharmacovigilance at various German Universities (under-and post-graduate studies).
ADI MEISTER
Teva
ADI MEISTER
Teva
ADI MEISTER, PV Sr. Manager, Teva
Experience:
Teva Pharmaceuticals
Senior Manager Global PV, Innovative and Developmental Products Safety Strategy
April 2019 - Present (3 years 10 months)
Teva Pharmaceuticals
Pharmacovigilance Manager, Risk Management Plans
2012 - April 2019 (7 years)
ratiopharm
Head of Drug Information 2, Labelling and Medical Affairs
2003 - 2012 (9 years)
Responsible Person for the Scientific Service of the MAH
ratiopharm
Manager Drug Information
1999 - 2002 (3 years)
Labelling
Sandoz
Pharmacist
1994 - 1995 (1 year)
Quality Control, HPLC
Skills:
- Pharmacovigilance
- Drug Labelling
- Risk Management
- Medical Affairs
- Project Management
- Decision-Making
- SOP
ROBERT M
Pfizer
ROBERT M
Pfizer
ROBERT MASSOUH, Director - Risk Management Product Lead, Pfizer
• Robert is a Risk Management Product Lead at Pfizer, supporting the development and execution of Risk Management strategies for Pfizer products.
• Robert has close to 10 years’ experience in PV and was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group.
• Robert is a registered Pharmacist and received his MPharm at the University of Manchester.
HUMAIRA Q
Qinecsa Solutions
HUMAIRA Q
Qinecsa Solutions
HUMAIRA QURESHI, President, Qinecsa Solutions
Senior Executive Leader with experience in leading successful Pharmacovigilance businesses in Health and Life Sciences Sector. A leader with strong management, strategic development and business development experience underpinned by extensive domain expertise over a 20+ year period.
RISHI CHOPRA
CSL Behring
PAV RISHIRAJ
Ipsen
PAV RISHIRAJ
Ipsen
PAV RISHIRAJ, Director – Pharmacovigilance & ABPI PV Expert Chair, Ipsen
• A senior Pharmacovigilance (PV)/ Patient Safety leader and expert with extensive detailed experience spanning 21 years across multiple functions including global/local positions, Pav Rishiraj has held previous senior management/leadership positions, primarily alongside QPPVs/VP of PV to ensure strict compliance to UK, European and global regulatory obligations through robust implementation and oversights of the regional/local PV system. His experience locally and regionally has enabled facilitation of strong cross-functional collaboration and transformational change across all the organisations he has served. A proactive leader and energizer, through inclusive, empowering leadership, Pav Rishiraj ‘s passionate advocacy and empowering approach to patient safety is apparent in full abundance when he was recognised and installed as the UK Chair of the ABPI Pharmacovigilance Expert Network (PEN). He remains ever committed to ensuring and propelling forward innovative approaches to patient safety and is currently a member of the International Society of Pharmacovigilance (ISoP).
• Pav has both strategic and working experience of influencing, shaping, and advocating the PV landscape from an industry perspective- recent highlights include pre/post BREXIT discussions with the MHRA, ABPI PV expert guidance’s in addition to industry lead wider impact groups. Internally, he has led many teams to audit and inspection successes. Notably, one of his career highlights was his strategic contribution to an overall company-wide R&D strategy.
• Pav was recently appointed (May 2022) as a member of the Board Steering Group (BSG) at the ABPI by his peers and colleagues to represent UK PV and drive forward Regulatory Science objectives largely to evolve a robust and respected regulatory framework with clear strategy for collaboration within the UK and internationally.
ELIAN KHAZNEH
Merck Healthcare
ELIAN KHAZNEH
Merck Healthcare
ELIAN KHAZNEH, Head of Global Patient Safety Benefit Risk Strategy & Mgmt, Merck Healthcare
Head of Benefit Risk Strategy and Management, GPS, Merck Healthcare.
In this role I lead a team of global process owners and experts in safety signal detection & Management, and benefit risk assessment & management from early development throughout the entire lifecycle.
FABIO D G
Shionogi Europe
FABIO D G
Shionogi Europe
FABIO DE GREGORIO, Vice President, Head of Drug Safety Europe, Shionogi Europe
• Dr De Gregorio serves as Vice President and Head of Drug Safety at Shionogi Europe, where he leads the European Pharmacovigilance Team.
• He has 25-year experience in the pharma industry in various roles, functions, and therapeutic areas.
• He has worked in pharmacovigilance since 2004 and spent more than 12 years as a QPPV.
• Among his achievements, he successfully set up the pharmacovigilance system of several small medium enterprises, and from the clinical development perspective, he received international awards for his researches on an innovative treatment for ocular hypotony.
• Dr De Gregorio graduated in Medicine from “La Sapienza” University of Rome, Italy, specialised in ophthalmology, which practised for over 20 years and has also a PhD in pathophysiology of ocular circulation.
RAJ BHOGAL
Jazz Pharmaceuticals
RAJ BHOGAL
Jazz Pharmaceuticals
RAJ BHOGAL, Sr. Director, R&D Business Strategy & Operations, Jazz Pharmaceuticals
• Raj Kaur Bhogal, Sr. Director in Business Strategy & Operations.
• Raj previously headed up the R&D Audits & Inspections Team within Global Quality at Jazz Pharmaceuticals.
• Raj is a Quality Assurance Professional with 23 years of diverse Pharmaceutical Industry experience based in the UK. With a broad expertise in different GxPs e.g., GVP, GCP and GMP. Her areas of subject matter expertise include Quality Management System & Pharmacovigilance System.
• Raj spent 8 years in various Manufacturing roles at Eli Lilly & Company where she started as a placement student as part of her degree.
• In Raj’s 12 years at Shire/Takeda in the R&D Quality team she had the opportunity to lead the inspection readiness program, she also managed and hosted MAH, Supervisory Authority & many local PV system inspections (e.g., UK, EU, China, Saudi Arabia, South Africa, Australia) and also MHRA GCP Inspection. Raj participated in various due diligence activities, mergers, acquisitions and integration activities with various companies.
FATIMA Y G
Makkah Healthcare Cluster
FATIMA Y G
Makkah Healthcare Cluster
FATIMA YOUSEF GHETHAN, Executive Administration of Institutional Excellence and Quality, Makkah Healthcare Cluster (Saudi Arabia)
LUIZ LIMA
Ipsen
LUIZ LIMA
Ipsen
LUIZ LIMA, Senior Medical Director, Ipsen
Senior Medical Director at Ipsen, working with clinical safety in early development. I have been working in PV for 13 years.
During this time, I have also worked with clinical safety in Phase II/III studies and post-marketing surveillance in a number of products across different Therapeutic Areas, and as head of a local PV team in the UK.
I qualified as a doctor in 2000, followed by a specialisation in Clinical Neurology, and practiced medicine for 10 years as a neurologist before joining the Pharma industry.
I’m an Affiliate Member of the Faculty of Pharmaceutical Medicine in the UK, I have a PG in Pharmaceutical Medicine, a PG in Clinical Research and a MSc. in Evidence Based Medicine.
My LinkedIn is https://www.linkedin.com/in/luizgustavolima
ANNA HELENA S
Bavarian Nordic
ANNA HELENA S
Bavarian Nordic
ANNA HELENA STAHL, Senior Director, Pharmacovigilance; EU QPPV, Bavarian Nordic
ALINA TUDOR
Kyowa Kirin International
ALINA TUDOR
Kyowa Kirin International
ALINA TUDOR, Senior Director, Pharmacovigilance, Kyowa Kirin International
• Alina Tudor is a medical doctor with over 16 years of experience as drug safety physician.
• She has worked for both speciality pharma and generic companies, in clinical development and post marketing risk management.
• She currently is a Senior Director Pharmacovigilance, leading global safety teams for Kyowa Kirin, working with drugs and biologics in the rare disease area.
ROHAN MANE
Pfizer
ROHAN MANE
Pfizer
ROHAN MANE, Director, Safety Risk Management Centre of Excellence, Pfizer
Rohan is skilled in Pharmacovigilance, Regulatory Requirements, CRO Management, Clinical Trials, and Pharmaceutical Industry.
He has been in Pharmaceutical Industry for over 16 years, with over 12 years’ experience in all Pharmacovigilance activities in global risk management strategy, safety surveillance, aggregate reports, regulatory writing, case processing, medical information, audits inspections and program & project management.
DNYANESHWAR S
Glenmark
DNYANESHWAR S
Glenmark
DNYANESHWAR SANAP, EU/UK QPPV, Head Regional Pharmacovigilance, Glenmark
• Dnyaneshwar or Dnyan (better known as Dan in indistry circle) is a qualified physician of Indian origin, with total experience of more than 17 years.
• Initiated career as a medical practitioner. After > 4 years of clinical practice experience and masters in pharmaceutical medicine (moreover upon developing interest into drug safety and clinical development field), joined pharma industry in 2009.
• His first encounter with PhV occured during pursuing masters training at a WHO zonal center for Indian National Pharmacovigilance program (KEM hospital, Mumbai; 2007-08)
• He has worked across PhV business models [academia (KEM Mumbai), vendor (TCS, Accenture), and sponsor-both developmental (AZ, UCB and BI) and post marketing (Sun /Taro and Glenmark)] since then.
• During his previous association with Boehringer Ingelheim, he was responsible for safety survillence of one of it’s blockbuster medicinal product and was involved in measuring effectiveness of additional risk minimisation measure and development of AI based tool for assessment of safety data.
• He is a qualified PV-QA auditor and a clinical trial medical monitor, has worked (as well as working) as EU-QPPV.
TEA BABIC
Teva
TEA BABIC
Teva
TEA BABIC, Director, Head of Global PV Audits and Inspections, Deputy Head PV Compliance, Teva
• I am a pharmacist with MSc in Clinical Pharmacology, and 18 years in pharmaceutical industry, in QA, PV and PV Compliance roles.
• After 3 years of working in QA in the beginning of career, I moved to PV where I gained experience with ICSR processing and reporting, periodic reports and RMP preparation before moving to PV compliance.
• I am conducting PV audits for 11 years and leading the PV audit and inspection group in Teva for the last 6 years.
SHARMILA S
Veeva Systems
SHARMILA S
Veeva Systems
SHARMILA SABARATNAM, Senior Director, Vault Safety Strategy, EU, Veeva Systems
Sharmila Sabaratnam is a Senior Director at Veeva Systems responsible for Vault Safety Strategy in Europe, helping customers transform their business through a unified safety solution. She is a physiologist by training with research experience in oncology and arthritis. Sharmila has 10+ years’ experience in safety, previously leading safety and regulatory advisory services for Top-25 and Top-100 companies at Ernst & Young and Navitas.
Her experience includes operating model design and safety strategy, PV automation, benefit-risk management, and performance benchmarking. As a senior leader within the NHS, Sharmila led R&D clinical operations with a large oncology clinical trials portfolio, including the Biomedical Centre for Translational Research.
GRAEME LADDS
PharSafer
GRAEME LADDS
PharSafer
GRAEME LADDS, CEO, PharSafer
• With a first degree in Biochemistry and Pharmacology, and a Ph.D. focusing on drug metabolism and Pharmacokinetics, Graeme has worked in the areas of Drug Safety and Medical services for over 30 years.
• Working as a Head of Global Pharmacovigilance for a multi-national innovator Company and EU QP PV for several of the top ten Pharma Companies, large generic and smaller innovative Pharma, Graeme is the CEO and Owner of PharSafer® – a position held for the last 19 years – and he has taken many products from bench to clinical to post-marketing in many global markets; helping many small start-up Companies (Biotech, Advanced Therapy, Medical Device, Biologic, Generics, Herbal, OTC) in their planning and growth, due-diligence activities for product in-licensing and marketing, and development strategies with partner and distributor Companies.
• Graeme has also been involved in many global audits (conducted) and inspections (taken part in) for clients and also database designs and development.
BRIAN EDWARDS
ISOP
BRIAN EDWARDS
ISOP
BRIAN EDWARDS, Director, International Society of Pharmacovigilance, ISoP
• Dr Edwards trained at Guy’s Hospital, London and spent 14 years in hospital medicine and clinical research before joining the UK regulatory agency which used to be called the Medicines Control Agency. After 5 years there, he joined a global CRO, Parexel, for six years followed by 18 months at Johnson & Johnson as a deputy qualified person for pharmacovigilance.
• For the last 13 years up until 2021, he was Principal Consultant in Pharmacovigilance at NDA Regulatory Science based in the UK.
• In addition, he co-chairs the ISOP Medication Error Special Interest Group) and Chair of the UK Pharmaceutical Human Factors group.
• Previously, he chaired the panel overseeing the ‘Drug Safety Surveillance’ module as part of Higher Medical Training for pharmaceutical medicine in the UK between January 2006 and 2012. He has been awarded a Fellowship with the International Society of Pharmacovigilance.
• Currently he is Managing Director of his own consultancy Husoteria Ltd and has been co-leader of the DIA/ASA BRAP working group since 2020. More recently, he was elected back to the Executive Committee of ISOP and is Vice-President and Director of ISOP Secretariat Ltd.
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA
CLINEXEL Life Sciences
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
Deepa is an Experienced Clinical Development and Drug Safety physician. She served in leadership positions in pharma companies for almost two decades, leading global clinical research and pharmacovigilance activities. Currently she is the Chief Executive Officer of Clinexel Life Sciences Pvt Ltd.
CLINEXEL is an agile, customer focused full service, Clinical Research Organization, that provides clinical research, pharmacovigilance, regulatory, auditing and medical writing services to pharma, biotech and medical device companies. At CLINEXEL, our mission is to partner with early-stage pharma and biotech companies for fast and efficient clinical development of their innovations.
MIJAL CHAVDA
Kyowa Kirin
MIJAL CHAVDA
Kyowa Kirin
MIJAL CHAVDA, Senior Director, Global Head of GxP Inspections & GVP Quality, Kyowa Kirin
ALESSANDRO V
MSD Merck Sharp & Dohme
ALESSANDRO V
MSD Merck Sharp & Dohme
ALESSANDRO VAGHEGGINI, Associate Principal Biostatistician, BARDS-CSS, MSD Merck Sharp & Dohme
Alessandro got his PhD in Statistics (2013) from University of Bologna, Italy and subsequently, he held a research fellow position in the same department for five years; his main research interests focused on environmental data and adaptive designs for clinical trials.
Since 2017, Alessandro worked as a Biostatistician Manager at the Biostatistics and Clinical Trials Unit of the IRST IRCCS oncology research hospital in Meldola (FC), Italy. There, his main tasks were the statistical design of clinical trials and analysis of data coming from different studies (clinical, biological, physical and psychological). At the same time, he carried on his methodological research on adaptive designs .
In 2020, Alessandro joined the Clinical Safety Statistics group at MSD; since then, he contributed to the success of several projects while pursuing methodological developments in the drug safety field coupled with adaptive designs and master protocols.
LUDIVINE D
Sanofi
LUDIVINE D
Sanofi
LUDIVINE DOUARIN, Benefit-Risk Expert, Sanofi
Ludivine is pharmacist by training with diploma in clinical development, statistics and quantitative epidemiology and a Master degree on real life evaluation of medicinal products, market access, and public health. She has more than 18 years of experience in different roles in Global Pharmacovigilance, starting in case management and safety analysis, than signal detection where she actively contributed to the development of the business process for quantitative signal detection and evaluation and dedicated tools, and risk management activities for a large number of marketed and investigational products across different therapeutic areas including rare diseases, diabetes and cardiovascular, oncology and multiple sclerosis.
Since 2018, she is a benefit-risk expert and leads the development of patient-centric benefit-risk assessments for drugs and vaccines in development from before phase 1 to pre-submission phases, and for marketed drugs and vaccines, in close collaboration with stakeholders from other functions (e.g., pharmacovigilance, pharmacoepidemiology, medical, regulatory, statistician, clinical development).
TOMMASO V
ITALFARMACO
TOMMASO V
ITALFARMACO
TOMMASO VENTURI, Corporate Pharmacovigilance Risk Assessment Specialist, ITALFARMACO
Tommaso Venturi is a PharmD, graduated at University of Padua with training in clinical pharmacology, epidemiology and data science.
After a brief experience in public health he worked for over 7 years in the pharmaceutical industry, in which he dealt with pharmacovigilance, clinical development and medical information.
As a consultant he worked as deputy EU QPPV and supported global pharmacovigilance risk evaluation activities.
Currently, he works as Corporate Pharmacovigilance Risk Assessment Specialist and covers the ad interim role of deputy EU QPPV in Italfarmaco, with responsibilities over safety evaluation, risk management and safety database administration.
He’s also member of an academic working group of the pharmaceutical department at University of Padua.
EMANUEL L
Otsuka Pharmaceutical
EMANUEL L
Otsuka Pharmaceutical
EMANUEL LOHRMANN, Lead Safety Physician, Otsuka Pharmaceutical
Lead safety physician at Otsuka Europe; joined drug safety/pharmacovigilance 17 years ago; held different roles in as safety physician in drug safety, pharmacovigilance, and pharmaco-epidemiology in different companies.
Main activities were signal detection and management, safety risk management, benefit-risk assessment in clinical development and post-marketing.
KAPIL BHUTADA
Medicago
KAPIL BHUTADA
Medicago
KAPIL BHUTADA, Director, Pharmacovigilance Compliance and Training, Medicago
• Kapil Bhutada MS BPharm, currently a Director, PV compliance, Training and Strategy at Medicago is Pharmacist by training and have Masters in Regulatory Affairs.
• Kapil have been in PV Industry for 15 years and worked in CRO, Big, Midsize and Small Pharma and biotech.
• He has experience in ICSR Processing, Training and Compliance, Signal management, Auditing and Inspection Hosting.
• In his current role, he is working on Covid-19 vaccine and supporting Medicago team with Benefit/Risk Management, Signal Management, Coordinating Real World Evidence Studies (Safety/Efficacy) and Inspection Readiness and Compliance activities.
BARTA K E
Gedeon Richter
BARTA K E
Gedeon Richter
BARTA-KONDAS ENIKO, Head Global PV Operations, Gedeon Richter
• Head of Global Pharmacovigilance Operation, Richter Gedeon Nyrt. in Budapest. A graduate of Bioengineering at Corvinus University of Budapest in 2015. Joined Richter Gedeon Nyrt. in 2016. Accumulated more than 6 years of experience in the pharmacovigilance area, managing worldwide operational activities.
• Responsible for leading and managing of outsourced activities for worldwide and local scientific literature screening, end-to-end case management, reconciliation. Overseeing the global system for the collection, processing and regulatory reporting of individual drug safety reports. Providing assistance and support for the work of the local pharmacovigilance officers of the subsidiaries. In charge of managing PV agreements with licence partners.
• Furthermore, ensuring cost-efficiency and daily compliance of pharmacovigilance systems especially of LifeSphere Safety MultiVigilance, LifeSphere EV Triage, Drug Safety Triager. Supervising a PV technology function and looking after system maintenance, change management, developing query strategy, enabling technology functions for business needs.
GAURI UTTURKAR
UCB
GAURI UTTURKAR
UCB
GAURI UTTURKAR, Patient Safety Physician, UCB
• Gauri Utturkar has more than 13 years of pharma industry experience, starting her career with a CRO and now having an extensive patient safety experience within innovator and generic pharma.
• A medical graduate by education, she started her work in early patient safety activities in clinical trials and gradually moved on to pharmacovigilance in one of leading generic pharma companies where in she worked on early and late patient safety activities.
• She also worked as deputy EU QPPV and UK QPPV in this company before moving on to innovator pharma space.
• She is currently working as Associate director, Patient Safety in the role of safety physician for one of the leading products at UCB Pharmaceuticals.
OLEKSANDR K
Olexacon
OLEKSANDR K
Olexacon
OLEKSANDR KARPENKO, Director, Olexacon
• Oleksandr Karpenko is a pharmaceutical physician, clinical and medical safety consultant and MD with Olexacon (London, UK). In his consulting projects Oleksandr leverages expertise and skills gained over 18 year of hands-on and management experience with Roche, AstraZeneca, Takeda, Servier and other companies.
• He has worked in medical capacity at various levels in global drug safety, from affiliate PV, global safety operations to global safety lead and therapeutic area head responsibility from preclinical to various stages of clinical and postmarketing safety surveillance.
• His industry therapeutic expertise includes oncology, gastroenterology, respiratory, metabolism, inflammation, and other areas. Oleksandr has MBA and MD degrees, with initial medical specialization in orthopaedics and traumatology, including 4 years of practicing medicine, licensed for practice in the UK.
• Oleksandr provides medical contribution to a range of services, including medical monitoring and data review, safety oversight of investigational and marketed products, signal detection and evaluation, risk management, safety contribution to design of clinical development programs and individual clinical trials, contribution to pertinent clinical documents and reports (IB, IMPD, study protocol, ICF, CRF, clinical study reports etc.) processes and decision criteria (safety reporting, stopping rules, go-no go criteria etc.), Data Monitoring Committees, training of investigators and service provider personnel.
• Oleksandr also leads from the medical safety perspective regulatory submissions (NDA, BLA, marketing authorisation applications), periodic and aggregate reports (PSUR/PBRER, DSUR, CTD 2.5 and 2.7.4, ACO, PADER etc.), as well as Risk Management Plans (RMPs), responses to regulatory requests and other regulatory interactions, ICSR medical review and other services.
MARIA B P
Scendea
MARIA B P
Scendea
MARIA BEATRICE PANICO, Principal Consultant, Scendea
Dr Maria Beatrice Panico is a Principal Consultant at Scendea, responsible for providing scientific and regulatory advice. Beatrice was formerly a Leading Senior Medical Assessor at the MHRA and represented the UK in the European working groups on new trial designs, safety and In Vitro Diagnostics. She is one of the authors of the CTFG Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials.
Before joining the MHRA she worked as a clinical neurologist, clinical investigator, researcher in neuroscience and pharmacovigilance expert in the pharmaceutical industry.
She is a member of the WHO working group on regulatory aspects of artificial intelligence and contributed to the SPIRIT-AI and CONSORT-AI guidelines.
Beatrice Is a medical doctor, fully qualified neurologist and has a PhD In neuroscience.
ALEXANDER R
Arnold & Porter
ALEXANDER R
Arnold & Porter
ALEXANDER ROUSSANOV, International Partner, Life Sciences and Privacy, Arnold & Porter
• Alexander Roussanov, a former senior legal adviser in the Legal Department of the European Medicines Agency (EMA), focuses his practice on a broad range of issues related to the life-cycle of medicinal products and medical devices. His experience includes product classification, authorization and conduct of clinical trials for medicinal products and clinical investigations for medical devices, marketing authorization for medicinal products and CE marking of medical devices, pharmacovigilance and device vigilance, marketing and promotion activities, privacy and data protection counseling, and interactions with health care professionals.
• He is well-versed in certain EMA-specific regulations, including those surrounding advanced therapy medicinal products, marketing authorization procedures, referral procedures, GxP inspections, the Agency's freedom of information policy and clinical data transparency. In addition, he has represented the EMA in litigation in the Court of Justice of the European Union.
• Mr. Roussanov advises clients on the form and terms of various types of agreements important for the efficient conduct of research activities including clinical study agreements, sponsor's representative agreements, registry agreements and CRO agreements. He also has experience in internal investigations, audits and regulatory due-diligence projects.
• He has extensive practical experience counseling organizations on data security and privacy matters. Mr. Roussanov has assisted clients with compliance requirements of Regulation (EU) 2016/679 (GDPR). He advises on many aspects of the GDPR that are of particular importance in the Life Sciences sector. These include the collection and processing of patients' personal health data and genetic data, transfer of personal health data outside the EU a nd the territorial scope of the GDPR.
Sample Attendees
Event Schedule
Meet and to network with your conference colleagues.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 – Chairperson opening remarks
OLEKSANDR KARPENKO, Director, Olexacon
MARKET TRENDS & WAY FORWARD
09:40 – Models for an International Pharmacovigilance function
In industry two main models for Pharmacovigilance in the affiliate space exist. This presentation looks to describe those models and describes the change management process when adapting from one model to another.
RISHI CHOPRA, Global Head of Pharmacovigilance Regions, CSL Behring
10:20 - Patient Safety & Risk Management Excellence For pharmacovigilance and drug safety
• What is the impact of using the risk management tool for PV and medication safety excellence
• What is the impact of using the patient safety tool for PV and medication safety excellence
• Pharmacovigilance and medication safety excellence
FATIMA YOUSEF GHETHAN, Quality Culture & Implementation Manager, Executive Administration of Quality & Patient Safety, Makkah Healthcare Cluster (Saudi Arabia)
10:50 – Morning Coffee / Tea & Networking
CHALLENGES & OPPORTUNITIES
11:20 – Keynote Panel Discussion: Refining the PV environment - Rising back from the pandemic
• Brexit and its effect on Pharmacovigilance in the EU
• Lessons learnt from the pandemic
• Staying ahead in the race - Current trends for PV, and new and future guidelines
• Outsourcing in Pharmacovigilance - Best Practices, Challenges and key consideration
• Best practices & the way forward
Moderator
DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
Panellists
FABIO DE GREGORIO, Vice President, Head of Drug Safety Europe, Shionogi Europe
YVONNE NANCIU, Country Head Pharmacovigilance, Bayer
RISHI CHOPRA, Global Head of Pharmacovigilance Regions, CSL Behring
BARTA-KONDAS ENIKO, Head Global PV Operations, Gedeon Richter
12:10 – Fit for future sourcing for Pharmacovigilance.
HUMAIRA QURESHI, President, Qinecsa Solutions
12:40 – Networking luncheon
QUALITY - SAFETY – SIGNAL DETECTION
13:40 – Panel Discussion – Quality, Safety & Signal Detection – Overall approach
• Traditional and innovative approaches for signal detection
• Hybrid method to produce precise results and improve patient safety
• Developing a global safety intelligence process
• Quality assurance and compliance
• Database automation - Natural language processing/machine learning database
• Exploring patient support and marketing research programs from a safety perspective
• Latest updates and hot topics
Moderator
OLEKSANDR KARPENKO, Director, Olexacon
Panellists
FATIMA YOUSEF GHETHAN, Quality Culture & Implementation Manager, Executive Administration of Quality & Patient Safety, Makkah Healthcare Cluster (Saudi Arabia)
ANNA HELENA STAHL, Senior Director, Pharmacovigilance; EU QPPV, Bavarian Nordic
ALESSANDRO VAGHEGGINI, Associate Principal Biostatistician, BARDS-CSS, MSD Merck Sharp & Dohme
MARINA SUVAKOV, Global Head Product Safety Surveillance, Philip Morris International
EMANUEL LOHRMANN, Lead Safety Physician, Otsuka Pharmaceutical
14:30 – Patient centricity and Benefit - Risk
In context of Benefit-Risk assessment patient experience data can be used for
• Assessing patients preferences and trade-offs for BR
• Identification of patient needs and relevant endpoints for patients
• Understanding impact of risks on patients and tolerability
LUDIVINE DOUARIN, Benefit-Risk Expert, Sanofi
15:00 – Application of a probabilistic algorithm in signal management
• Validation of the algorithm
• Use in signal detection
• Use in signal validation
FABIO DE GREGORIO, Vice President, Head of Drug Safety Europe, Shionogi Europe
15:30 - Afternoon Tea/Coffee
15:50 – Case Processing – The Most Important Part of Pharmacovigilance?
• Reviewing the current industry landscape for clinical and post marketing drug safety
• Identifying and highlighting of key issues Companies face and how this influences safety data capture and processing
• Exploring how AI & Automation can provide a complete solution
GRAEME LADDS, CEO, PharSafer
SPONSOR – SITE – CRO - PATIENTS
16:20 - Panel Discussion – Rethinking relationship between Sponsor – Site – CRO & Patients – Working together for safety
• Proper communication between - Sponsor – Site – CRO & Patients
• Best Practices in Pre-Screening before selecting your partner
• How can you maximize the effectiveness of your partnership?
• Working together to improve drug safety
• Patients involvement for a better PV knowledge - Patient support programs
• Mistakes that will doom a CRO-Sponsor partnership
Moderator
OLEKSANDR KARPENKO, Director, Olexacon
Panellists
SUMIT MUNJAL, Vice President, Global Patient Safety Evaluation, Takeda Pharmaceuticals
BRIAN EDWARDS, Director, International Society of Pharmacovigilance, ISoP
DEEPA ARORA, Founder – Director, CLINEXEL Life Sciences
17:00 - Chairperson’s closing remarks and end of conference
17:10 – 18:10 - Networking Drinks Session
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 – Chairperson opening remarks
OLEKSANDR KARPENKO, Director, Olexacon
PV FOR FUTURE
09:40 – Demystifying device / product malfunction for PV
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen
10:20 – A cross functional approach for benefit risk strategy, management, and documentation
• Benefit Risk Strategy Document as a solution for core benefit risk and safety planning throughout the lifecycle
• Process for the creation and management of these documents
ELIAN KHAZNEH, Head of Global Patient Safety Benefit Risk Strategy & Mgmt, Merck Healthcare
10:50 – Morning Coffee/Tea & Discussion
PATIENT SAFETY
11:10 – Keynote Panel Discussion: From policy to practice: Prioritising Patients
• Driving patient centricity into your PV plans
• Developing a prioritisation framework for patients
• Patient-Perspectives in benefit-risk assessments
• A review of general issues and the specific challenges with patients
• Reshaping patient safety - Next generation pharmacovigilance for enhanced patient safety
Moderator
YVONNE NANCIU, Country Head Pharmacovigilance, Bayer
Panellists
JOHN SOLOMON, Head of Pharmacovigilance - UK & Ireland, Sanofi
ADI MEISTER, PV Sr. Manager, Teva
LUIZ LIMA, Senior Medical Director, Ipsen
ROHAN MANE, Director, Safety Risk Management Centre of Excellence, Pfizer
12:10 – Unify Safety Content Management for Single Company Voice on Product Benefit-Risk
SHARMILA SABARATNAM, Senior Director, Vault Safety Strategy, EU, Veeva Systems
12:40 – Networking luncheon
RISK MANAGEMENT & PLANNING
13:40 – Panel Discussion – Developmental risk management plans in Pharmacovigilance
• Impact of changing regulations and the dynamic nature of European RMP for safety concerns
• Guidance on risk management plans
• Managing risks / Administrating risks – Right way in handling situations
• Tailored approaches towards benefit-risk evaluations
• Risk management in different jurisdictions
• New approaches to managing benefit-risk
Moderator
ALINA TUDOR, Senior Director, Pharmacovigilance, Kyowa Kirin International
Panellists
ROBERT MASSOUH, Director - Risk Management Product Lead, Pfizer
DNYANESHWAR SANAP, EU/UK QPPV, Head Regional PV and Global Compliance & Training, Glenmark Pharmaceuticals
TOMMASO VENTURI, Corporate Pharmacovigilance Risk Assessment Specialist, ITALFARMACO
KAPIL BHUTADA, Director, Pharmacovigilance Compliance and Training, Medicago
GAURI UTTURKAR, Patient Safety Physician, UCB
IMPACT OF TECHNOLOGY
14:30 – Artificial Intelligence (AI) tools and pharmacovigilance
• Improving coding of adverse events via AI
• Natural language processing for case narrative review
• AI algorithms for signal detection
• AI and biobanks
MARIA BEATRICE PANICO, Principal Consultant, Scendea
14:50 - Afternoon Tea/Coffee
AUDITS & INSPECTIONS
15:10 – Panel Discussion - Plan, develop and implement the PV Audit strategy plan
• PV Inspection readiness: What to expect? How ready can we be?
• PV Inspection Readiness from inspector perspective
• PV Audit Readiness from auditor perspective
• Methodologies, scope and oversight
Moderator
MIJAL CHAVDA, Global Head of GxP Inspection & GVP Quality, Kyowa Kirin
Panellists
RAJ BHOGAL, Sr. Director, R&D Business Strategy & Operations, Jazz Pharmaceuticals
FABIO DE GREGORIO, Vice President, Head of Drug Safety Europe, Shionogi Europe
TEA BABIC, Director, Head of Global PV Audits and Inspections, Deputy Head PV Compliance, Teva
KAPIL BHUTADA, Director, Pharmacovigilance Compliance and Training, Medicago
REGULATION OVERVIEW & UPDATE
16:00 – Panel Discussion: Regulatory - EU and UK Regulations & Guidelines in Pharmacovigilance
• PV System Legislation Updates
• Key current changes and their impact on current PV
• Brexit – Regulatory aspect
• Outsourcing concepts and regulation implementation
• Future Legislation: Pharmacovigilance – Industry Vision
• Enhancing communication between regulators, regional authorities and patients
Moderator
PAV RISHIRAJ, Director – Pharmacovigilance & ABPI PV Expert Chair, Ipsen
Panellists
MICHAEL BEAN, Senior Director, Regulatory Compliance R&D, Johnson & Johnson
MARIA BEATRICE PANICO, Principal Consultant, Scendea
ALEXANDER ROUSSANOV, International Partner, Life Sciences and Privacy, Arnold & Porter
16:50 - 17:00 – Chairperson’s closing remarks and end of the conference
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Event Sponsors & Partners
PharSafer
Founded in 2003 by Dr Graeme Ladds, PharSafer® is a Global Contract Research Organisation (CRO) specialising in Global Clinical and Post Marketing Drug Safety, and Medical Services.
We offer an extensive range of vigilance services, ranging from Pharmacovigilance; Cosmetovigilance; Materiovigilance; Vaccine Vigilance; Nutrivigilance; Veterinary Pharmacovigilance; assisting with audit preparedness; performing global medical services; running industry training courses for industry professionals – ranging from introductory, through to intermediate and advanced – and more.
Together with our sister company SaPhar Training®, PharSafer® continuously seek new and innovative ways to provide added value for our clients, with the aim of optimising the processes and procedures involved with clinical and post marketing drug safety reporting.
With reporting procedures in place and ready to meet safety reporting regulations (clinical and post marketing) in over 130 countries, we ensure all of our activities and communications are conducted with full transparency, guiding our clients through the maze of global safety and medical affairs legislation, in the interest of patient safety.
PharSafer® are more than a provider. Like a family, we care deeply about our customers; our service; our reputation; our customer’s reputation and our people.
We love what we do. We love finding solutions.
Quite simply, we are by far… Your leading partner in drug safety
Visit our website: www.pharsafer.com
Qinecsa Solutions
• Qinecsa is a trusted partner to global life science companies. We bring together best-in-class technology and scientific expertise to connect life science companies to the right safety solutions.
• Patient safety is at the forefront of pharmacovigilance. In a demanding and constantly evolving field, life science companies need expert partners with the right people, processes, and technologies, to generate vital safety insights, rapidly.
• Through our unique insight into the challenges of pharmacovigilance, we have created industry-leading, end-to-end solutions for capturing, managing, and evaluating drug safety data, more efficiently and accurately. Working with life science companies we drive progress to continue protecting lives.
• We are Qinecsa. Advancing drug safety solutions to the next level.
Visit our website: www.qinecsa.com
CLINEXEL Life Sciences
CLINEXEL is a full service CRO. We provide science driven customized, cost- effectiveand time sensitive efficient early phase clinical development solutions. We are providing end to end clinical trial, regulatory, pharmacovigilance and medical writing services to pharma, biotech and medical device companies.
CLINEXEL Senior Management have strong experience in large pharma and biotech companies therefore, understand the business needs and challenges of clinical development, and key aspects of life cycle management of pharmaceuticals.
We are supporting small and mid-size pharma and conducting Phase 1, 2 and 3 Clinical Trials for NCEs and Biologicalsand Pharmacovigilance regulatory compliance activities.
Visit our website: www.clinexel.com
Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,100 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.
Visit our website: www.veeva.com
Brookwood Global
Brookwood Global
Brookwood has been providing training since 1985. As well as numerous courses in GCP, risk management, GDPR and other related areas, Brookwood has developed six online, on-demand pharmacovigilance courses. These have been developed by Prof Dr David Hutchinson with PV and CQA specialist Lisbeth Tofte Hemmingsen. If you wish, all courses can be fully customized to meet client’s needs as well as branded with logo and corporate colours. They can be provided as managed training (registration, tracking, reporting, certification) or as Scorm files to run on a client’s own learning management system.
Summaries of all of Brookwood courses can be seen in the online brochure and in a paper copy to be provided at the 31st Pharmacovigilance 2023 conference in London.
https://brookwood-global.com/Brochures/Online-Training/
Brookwood’s PV course titles include …
- PV for ALL – a short 15 min module for anyone in an organisation, from receptionist to general manager, who is likely to encounter product safety information.
- Essential PV – a 60-min course for those needing more in-depth knowledge of generic PV requirements.
- PV for the Local Safety Contact and L-QPPV – for those in affiliates with a PV role and for those working with local Safety Contacts.
- PV Refresher – an interactive Q&A style course to refresh PV knowledge.
- Essential Safety Reporting for the Study Site – a short course to remind investigators of their safety reporting responsibilities.
- Are you ready for a PV inspection? – a guide for anyone needing to be ready for a PV inspection.
All modules are in English, but can be translated into any language at client request. Plenty of interaction, personalization, narrated or read-only options and integral quizzes to test knowledge are features of Brookwood courses.
Brookwood is also able to develop bespoke online training using your own content.
Feel free to contact us if you would like to evaluate any of the courses in our brochure.
Visit our website: www.brookwood-global.com
Quanticate
• Quanticate is one of the world's largest global data-focused Clinical Research Organisation (CRO), primarily focused on data capture, statistical analysis, and clinical trial reporting.
As an expert in Clinical Data, high-quality teams can be provided to offer flexible solutions for:
• Clinical Data Management
• Biostatistics
• Statistical Programming
• Pharmacovigilance
• Medical Writing
• Statistical Consultancy
• With the launch of QVigilance in 2018, Quanticate focused even more on providing comprehensive pharmacovigilance (PV) and risk management services for Sponsors of clinical trials and Marketing Authorisation Holders.
• Quanticate's reach is global, with offices across three continents, and the solutions offered are customer-focused, from fixed cost or functional service provider (FSP) models to consultancy.
• By offering high-quality, value-added flexible solutions that meet current and future development needs, Quanticate has become the trusted supplier of choice for many companies, from niche biotechnology and device companies to top-tier pharmaceutical giants.
"We are committed to delivering quality-driven pharmacovigilance services and working collaboratively and flexibly with our customers. Together, we work towards continuous improvement in understanding the profile of our customers' products and thereby safeguard patients."
Visit our website: www.quanticate.com
Virtue Insight
CONCEPTUALISED BY
Virtue Insight
CONCEPTUALISED BY
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.
Testimonials
Bayer Country Head Pharmacovigilance
Bausch Health PhV Manager
Pfizer Country Safety Lead UK & Ireland
Boehringer Ingelheim Emerging Markets
Takeda Regulatory Inspection Lead, Safety & International Global Quality
Teva Pharmaceutical PhV Manager
CSL Behring Director, Clinical Safety Physician
Vifor Pharma Global Head Medical & Clinical Drug Safety
Amgen Safety Executive Director
Shire Pharmaceuticals Safety Executive Director
Venue Details
Venue:
Radisson RED London Heathrow
Address: Middlesex, Bath Road (Building B), West Drayton, Heathrow UB7 0DU, United Kingdom
Phone: +44 20 8283 2030
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
