Faculty – Pharmacovigilance Audit and Inspections Conference

Deepa Arora
Vice President Pharmacovigilance and Global Head, Drug Safety and Risk Management, LUPIN LIMITED

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Dr. Deepa Arora is Vice President Pharmacovigilance and Global Head Drug Safety and Risk Management with Lupin Limited. She is a Physician, having more than 18 years of experience in drug safety and clinical development in the pharma industry and academia.

She has successfully set up world-class Pharmacovigilance systems for Lupin & Lupin subsidiaries in US, Europe, Japan and Australia. Under her able leadership, Lupin has successfully cleared Pharmacovigilance inspections conducted by regulatory authorities across the world.

She is playing an active role in developing awareness and skills of pharmacovigilance in the region by designing teaching modules in Pharmacovigilance & conducting training for medical institutions. She believes in finding innovative solutions to facilitate the translation of PV regulations in enhanced patient safety. She has authored the book on Pharmacovigilance; “Pharmacovigilance- An Industry Perspective” to help youngsters learn relevant aspects of Pharmacovigilance.

Raj Bhogal
Regulatory Inspection Lead, Safety and International R&D Quality Assurance and Compliance, SHIRE

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Currently working as a regulatory inspections Director in R&D Quality Assurance & Compliance at Shire within the safety and international centre of excellence. With over 18 yrs experience of working in the pharmaceutical industry.

Responsible for the management of Pharmacovigilance system related inspections globally and this includes inspection readiness preparation, hosting, CAPA management and follow up as required. Global experience of working with regulatory agencies e.g., MHRA, FDA, EMA, SFDA and many more health authorities.

Previous roles included auditing of PV system processes, affiliates, vendors, licensing partners, distributors etc.

Strong quality management system background which includes procedural document management, training, deviation and CAPA management. Started my career with 8 years of GMP experience working in a manufacturing facility at Lilly.

Deanna Montes de Oca
Associate Director, PV Operations Clinical Safety and Pharmacovigilance, OTSUKA

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Deanna holds a doctorate in Pharmacy and is a seasoned pharmacovigilance professional who has been leading the Otsuka Global Pharmacovigilance (GPV) department in an effort to harmonize our PV processes over the last six years. Deanna is a key member of the Otsuka management team currently leading and supporting many key initiatives. She has over 14 years of operational experience within the global pharmaceutical industry. Dr. Montes de Oca is a subject matter expert in pharmacovigilance operations, quality and analytics, and compliance. She has been a key leader and contributor for successful inspections with the FDA, MHRA, BfArM, EMA, and TGA. Dr. Montes de Oca has extensive experience and knowledge of vendor transition, management and oversight, safety database upgrades, and merging of multiple global safety databases.

Suzanne Elliott
Director (Head), U.S. Medical Compliance, BOEHRINGER INGELHEIM

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Suzanne Elliott is currently a Director, PV Quality Compliance Management, at Vertex Pharmaceuticals in Boston, MA for the last 5 months.  Responsible for Managing the Quality Assurance Program and overseeing Company PV activities relative to GxP industry standards, laws, and regulations.  Sue is also a leader in strengthening and executing on the Quality Management System within Vertex.  In addition, she is leading the Risk Management efforts within the Quality Management System. 

John Elzer
Associate Director, Audit and Inspection Readiness, PV Quality, SANOFI

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John Elzer is Associate Director working in Audit and Inspection Readiness of Pharmacovigilance Quality at Sanofi in Bridgewater, NJ which he joined in 2006. In this role, John is responsible for managing GVP, GCP, GMP, Business partner and Third Party Audits and Inspections. He has implemented a Business Partner and Third Party vendor audit program within PV Quality over the past two years. John also has previous experience at Sanofi as the Global Head of Training for PV developing and overseeing training curriculum for all PV associates globally. Prior to joining Sanofi John spent 5 years with Pfizer working in Drug Safety in various aspects of Case Management. John holds a BS in Pharmacy from Rutgers University.

Paula Engle
Head of Global PV Compliance, Training and PV Network, GE HEALTHCARE

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Paula Engle has been in the pharmaceutical industry for 15 years focusing on Pharmacovigilance. In 2013, she joined GE Healthcare as Manager of PV Compliance. In 2015 she was named Head of Global PV Compliance, Training and PV Network focusing on PV quality activities such as inspection readiness, SOP & training management and oversight of worldwide PV affiliates.

Prior to joining GE Healthcare, she worked for 10 years at Merck in various Drug Safety/Pharmacovigilance roles. She attended the University of Pittsburgh School of Nursing and before joining industry worked in the inpatient hospital setting and managed a family medicine clinical practice.

Marissa Fernandez

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Dr. Marissa Fernandez is the current country head of Baxter’s Patient Safety department in Canada. Marissa is both a pharmacist and a medical doctor by training with more than 25 years of comprehensive knowledge and cross-functional experience in pharmacovigilance, regulatory affairs and quality assurance within the pharmaceutical industry. Marissa has held various roles with increasing responsibilities, is recognized for operational excellence, and has successfully led various national inspections and audits. Marissa has thorough knowledge of pharmacovigilance principles and regulations, including Health Canada, ICH guidelines and the European Medicine Agency’s Good Pharmacovigilance Practices modules. Marissa is concurrently a part-time faculty in the Regulatory Affairs Program of Humber College’s School of Health Sciences in Canada, where she is responsible for courses in medical products safety, regulatory legislations and submissions. She has also recently completed her Certified Quality Auditor Certification from the American Society of Quality.

Patrick Hoegen
Associate Director, PV Quality and Compliance, ALKERMES

Ram Josyula, Continuous Improvement Master Black Belt Coach, BRISTOL-MYERS SQUIBB

Ram Josyula
Master Black Belt Coach and AI Consultant, BRISTOL-MYERS SQUIBB

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Ram is a Lean Sigma master coach and AI consultant specializing in process design, continuous improvement and robotic process automation (RPA) using lean, six sigma and AI techniques at BMS, GE, Ford, BP, eBay, Cisco and HP. He has guided dozens of global R&D projects in discovery, clinical operations, and pharmacovigilance that created a value of over $20 million. He has been mentoring and developing Master Coaches in Pharma industry since 2007. Ram holds Master of Science degree from MIT in Technology Management and Policy and Bachelor of Technology from IIT Madras. His specialty is leadership development, program deployment and value creation in highly regulated industries such as pharmaceuticals and nuclear energy.

Kevin Malobisky
Senior Vice President Regulatory, Quality, and Pharmacovigilance, KARYOPHARM

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Dr. Kevin P. Malobisky is a seasoned executive in the pharmaceutical and biotechnology arenas with professional experience in clinical and regulatory drug development, quality assurance, and pharmacovigilance. As a professional with over 26 years of experience, Dr. Malobisky has provided global leadership, management, and strategy across numerous therapeutic domains while working for companies and organizations in the public and private sectors. Kevin earned his bachelor of science degree in microbiology from the Pennsylvania State University, his masters of science in quality assurance and regulatory affairs from the Temple University School of Pharmacy, and his doctorate in organization management from the Capella University School of Business and Technology. Dr. Malobisky is currently the senior vice president of regulatory, quality, and pharmacovigilance at Karyopharm Therapeutics, a clinical-stage biotechnology company developing first-in-class selective inhibitors of nuclear export proteins for the treatment of hematologic and solid organ cancers. He is a member of the senior executive and leadership teams.

Rena Pandit
Director, Inspection Readiness Global Patient Safety and Epidemiology (GPSE), ALLERGAN

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Rena Pandit is the Director of Inspection Readiness for the Global Patient Safety & Epidemiology(GPS&E) group within Allergan. In this role Rena is responsible for the development, implementation, and maintenance of a Global Inspection/Audit readiness program for audits and health authority inspections for the GPS&E group. She is also responsible for review of relevant procedures, regulatory requirements, gap analysis and mock interviews with relevant colleagues and collaborating with key stakeholders to proactively mitigate compliance risks.

Rena has more than a decade of experience in Pharmacovigilance. Her previous roles include being appointed Deputy EU QPPV for Arrow Generics in the UK, as well the Head of Allergan’s Global Case Processing department. Rena has also spent time as a Pharmacovigilance Consultant taking on various projects including providing input into best pharmacovigilance practices, creating and maintaining PV System Master Files, streamlining PV procedures and creating training materials and competency testing for pharmacovigilance staff. Previous to entering the Pharmaceutical world Rena spent time working in hospital and retail pharmacy.

Rena holds a Pharm.D. from the University of Southern California (USC).

Sameer Thapar
Assistant Professor and Advisor, Drug Safety and Pharmacovigilance Rutgers, THE STATE UNIVERSITY OF NEW JERSEY

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Dr. Sameer Thapar holds a doctorate of pharmacy (PharmD) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US and has held an academic role of Professor, Drug Safety and Pharmacovigilance at Rutgers University. Dr. Thapar has over 20 years of experience in operations within the pharmaceutical, biotech, and CRO industries, with cross-functional experience in medical affairs, clinical operations, quality assurance, and subject matter expertise in pharmacovigilance operations and compliance. He has built global departments and defended in successful FDA, MHRA, and EMA health authority inspections. Dr. Thapar is an active advisor in US based life science industry conferences and participates as an invited speaker and panelist in global industry conferences.

Boris Videlov

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Boris Videlov, MS, PMBA, is a Head of PV Licensing at Pfizer, which he joined in 2012. In this role he is responsible for managing the PV Licensing function; leading the development and execution of long-term PV Licensing strategy, systems and processes development; and end-to-end execution of the process governing PV relationships with business partners.

He joined Pfizer from Forest Laboratories, where he was the Head PV Quality Assurance, R?D QA, responsible for conducting and hosting all PV audits, regulatory inspections, Due Diligence, and operational QA activities. Prior to that role he was the Head of Compliance ? Quality Management at Forest Global Drug Safety, with responsibilities for assessment and management of compliance risk, monitoring and improvement of quality of safety information and procedures, and the development and maintenance of the PV Quality Management System.

Prior to Forest Research Institute, Boris Videlov served as a Manager Contract ? Project Management, Global Pharmacovigilance at Schering-Plough Research Institute. During this period he was responsible for negotiating global Pharmacovigilance Agreements in compliance with the international and local laws and regulations, developing Global Pharmacovigilance Standards, and other PV project management and operational activities.

Boris Videlov began his career as a research fellow in the area of neurophysiology in 1981, and held various positions in pharmaceutical Drug Safety, Regulatory, Marketing, Consulting, and Scientific Research during his 20+ years professional experience. Boris Videlov holds a Post-MBA in Pharmaceutical Management from Fairleigh Dickinson University, MBA in Management from Long Island University, and MS in Biochemistry and Microbiology from Sofia University. Furthermore, he has published in Electricity and Magnetism in Biology and Medicine.

Susan Welsh
Chief Safety Officer, CSL BEHRING

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CSL Behring is a global company which conducts business in 60 countries and is headquartered in Australia. The company has a remarkable and industry-leading patient-centric approach truly placing patients first and foremost. Currently, the company is experiencing strong growth and is expanding. Susan heads the global PV function at this exciting and dynamic company. She has 28 years of industry experience with over 15 years overseeing PV directly or as part of clinical development/medical affairs roles. Before CSL, Susan served as Chief Safety Officer of Sanofi, VP of Safety Strategy at Pfizer, and VP Medical Safety at BMS.

Earlier in her career, Susan held senior roles in medical affairs, clinical development, general management, finance and IT. She worked as Chief Knowledge Officer at Monsanto and then as Corporate Officer, SVP and Chief Science Officer at Express Scripts, establishing the company by designing formulary strategies e.g. multi-tier formulary and specialty distribution services and co-founding one of the world’s first real-world evidence companies, Practice Patterns Science. Following this, she served as CEO Charis Pharma and as CEO Snowdon Pharma successfully transferring the companies on when key milestones were achieved.

Susan holds an MBChB (British equivalent MD) and Bachelor of Science from University of Leeds, UK. Her Master’s Information Management is from Washington University, St. Louis, USA, and her MBA is from the University of California at Berkeley, USA. Susan is a licensed physician with UK practicing rights. She is an elected Fellow, Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians UK (FFPM), Member, Royal College of General Practitioners, UK and Royal College of Psychiatrists UK, Diplomate, Royal College of Obstetricians & Gynaecologists UK, and Member, American College of Physicians.

Before industry, Susan practiced medicine for 10 years in the UK, later serving for 6 years as a military officer in Britain’s Royal Air Force being promoted to the rank of Squadron Leader and completing many military challenges around the world.

Richard Wolf
Senior Director Regions and Pv Operations, Global Clinical Safety and Pharmacovigilance, CSL BEHRING

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Rich Wolf is Senior Director, Regions & Pv Operations in the Global Clinical Safety and Pharmacovigilance group at CSL Behring. He directs Case Management, Medical Evaluation, Pv Systems, and the Regional organization responsible for Pv in affiliates around the world.

CSL Behring is a global leader in the plasma protein biotherapeutics industry. They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions. Users of their therapies rely on them for their quality of life and, in many cases, for life itself. Corporate Headquarters are in King of Prussia, Pennsylvania in the United States and its parent company CSL is headquartered in Melbourne Australia.

Rich joined CSLB in 2014 after 12 years with Johnson & Johnson serving a number of different roles across Drug Safety, Benefit Risk Management, and Global Medical Safety. He has a BA from the University of Richmond, and MBA from Rutgers University is PMP certified in project management.