Global Pharmacovigilance Requirements

PV Associate Director; Yingxia has 14-years' working experience in China Pharmacovigilance at Sanofi and Boehringer Ingelheim from 2011, and 4-years' working experience in pre-clinical research at Stealth Peptides from 2007. Also is a member of China Quality Assurance Forum (CQAF) PV Working Group.

PV Physician Yanjie has 7-years' working experience in China Pharmacovigilance at IQVIA, Celgene and Boehringer Ingelheim, and 4-years' working experience in nutritional products adviser and medical information handling at Sanofi, Roche Diagnostics and Eli Lilly.

Deputy General Director "Technical Affairs" 15 years’ experience in different fields comprising RA and IPR in the pharmaceutical area. As a member of SIPSMENA team, Ala’a has been subjected to various other areas in the pharmaceutical industry such as agent selection, legal requirements, market access and others.
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Chief Operating Officer; Jennifer (Jen) True is a pharmacist with over 25 years of experience in the pharmaceutical industry. Her career has been focused in the areas of Drug Safety/Pharmacovigilance (PV), Project Management, Quality, and Training. During her time at Abbott and Lilly, she performed all types of PV activities (e.g., case processing, signal management, aggregate reporting). She also managed global safety organizations of various sizes, covering a very broad spectrum of PV activities. Jen spent several years in pharmaceutical consulting with companies such as Ernst & Young/Cap Gemini, Seibel/Oracle, and Galt. She has successfully managed multi-million-dollar projects focused on technology implementation, process redesign, and acquisitions. Over her career, Jen has provided quality support to PV, Regulatory, Clinical (phase I-III), Clinical Labs, Companion Diagnostics, and Sales & Marketing departments. She has redesigned quality systems and managed multiple audits and regulatory inspections (FDA, EMA, MHRA). Jen has worked on numerous human resource initiatives, including improvement of organizational design, development of job descriptions, and creation of competency models. She has actively led training programs, including forming of training strategy and development of training and training matrices. She is known for her practical approaches, communication skills, ability to manage both strategy and implementation details, and follow-through.

Founder and CEO; Dr JP Clement is the Founder and CEO of JPCC Associates. He has worked over the last 35 years in Drug Safety and PV in multiple capacities, including managing worldwide functions, building or improving PV organizations to meet the highest standards, and leading a consulting group since the last 11 years. Prior to consulting, Dr Clement worked for several biotech and large companies such as Janssen, Merck KGaA, Abbott, Sanofi, Onyx and Cubist. Dr Clement has a track record of implementing highly efficient PV groups and activities, with high strategic output and compliance levels. He has also guided organizations to successfully manage critical hurdles such as PV inspections, market approval, expansion of global PV footprint and handling of safety crises. He has been part of the Annual DIA Pharmacovigilance and Risk Management Strategies for several years, both as a member and in a chairmanship role. He has been a regular guest speaker for several international PV seminars. In his consulting practice, he has aided with the establishment of highly compliant and effective PV organizations within multiple pharmaceutical companies, elevating PV contributions to a strategic level, and acting as fractional Head of PV for several companies. Dr Clement graduated with a degree in Family Medicine from Sorbonne Medical University in Paris, France. He studied Pharmacology at medical universities in Paris and Lyon, France. Dr Clement worked for 8 years in clinical practice prior to joining the pharmaceutical industry.

Dr Petra Lerner-Hiller has more than 25 years of experience in leading positions in the pharmaceutical industry in the areas of quality assurance (GVP, GCP) and pharmacovigilance, including the functions of German "Stufenplanbeauftragte" and EU QPPV. In her current role, Dr Lerner-Hiller is Deputy QPPV and also PV System Strategy and QPPV Relations Lead, responsible for the strategic oversight of the pharmacovigilance system including its quality management system and communication with local QPPVs word-wide.

Dr Rehak is an expert on registration and PV in Russia and EAEU. From 2011 to 2014, she has been working as Regulatory Director at Sanofi and Medical Director at Zentiva, based in Moscow, and prior to that, from 2006 to 2009, as Head Regulatory and QA for Novartis, based in Kiev, Ukraine. Until 2006, she held several positions in product development and clinical research at Sandoz/HEXAL, Germany. She offers consultancy services in registration of medicinal products and PV in Russian and EAEU.
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Pharmacovigilance leader FIFARMA and Patient Safety Lead for Roche Colombia; Diana María González is a physician specialising in public health (University of La Sabana), with a master’s degree in health business administration (EAN University), and is currently studying Medical Law, Biolaw, and Bioethics at Universidad del Rosario. She has additional qualifications in pharmacovigilance, risk management, patient safety, immunology, pharmacology, leadership, and communication. She has 15 years of experience in the pharmaceutical industry, including over 13 years in leadership roles in pharmacovigilance, risk management, regulatory and medical affairs. As a national and international speaker, she regularly presents on pharmacovigilance, risk management, patient safety policies, and regulatory harmonisation. Currently, Diana leads the Pharmacovigilance Subgroup at FIFARMA and serves as Patient Safety Lead at Roche Colombia, while also contributing to industry committees at the Latin American level.

Regulatory Affairs Director; Diego Salas is the current Director of Regulatory Affairs at FIFARMA, the Latin American Federation of the R&D Pharmaceutical Industry. He is responsible for leading regulatory policy and regulatory intelligence for the industry in the region. He is a specialist in pharmaceutical management and pharmaceutical market, holding a master's degree in intellectual property and international trade, as well as a bachelor's degree in law. Diego is a member of the steering committee of the Pan American Network for Drug Regulatory Harmonization (PARF Network), part of the organizing committee for the DIA Latin America annual conference, and has over 14 years of experience in regulatory affairs, pharmacovigilance, and regulatory policy both in Latin America and globally.