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6th Pharmacovigilance & Drug Safety Online Summit

  • 3rd – 4th December 2020
  • Zoom flag Zoom
  • ONLINE CET

Having run five successful events, we are glad to announce that the 2020 6th Pharmacovigilance & Drug Safety event will be held online and will focus on the latest trends and regulations in Pharmacovigilance, including industry trends, regulatory challenges, best practices of quality risk management, signal detection, and PV data management.

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Who should attend:

Vice Presidents, Directors, Chief Executives, Department Heads, Leaders, Managers and Technologists specialising in:

  • QPPV
  • Risk Management
  • Pharmacoepidemiology
  • Signal Detection/ Signal Management
  • Pharmacovigilance
  • Risk Assessment
  • Market Research Programs
  • PV Governance
  • Phase IV/Postmarketing Safety
  • Drug /Product Safety
  • Patient Safety
  • Medical Affairs
  • Quality Assurance
  • Regulatory Affairs/ Compliance
  • Audit Readiness
  • Medical Safety
  • Safety Surveillance/ Management
  • Clinical Data Management/ Analysis
  • Drug Development
  • Clinical Trial Management
  • R&D

JOIN THE ONLINE EVENT!

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

  • Quality risk management
  • Regulatory challenges
  • Signal detection
  • Data management
  • Managing new technologies in safety
  • New EU Clinical Trial regulations
  • EU QPPV - latest trends
  • MHRA and FDA PV inspection trends
  • Compliant and scalable outsourcing in PV

JOIN THE ONLINE EVENT!

Raj Bhogal, UK

Senior Director, Head of R&D Audits & Inspections

Jazz Pharmaceuticals

Raj is an MSc qualified Quality Assurance Professional with 20 years of diverse Pharmaceutical Industry experience based in the UK. Broad expertise in different GxPs, e.g., GVP, GCP, GMP, and GDP. Areas of subject matter expertise include Audits & Inspections, Quality Management System & Pharmacovigilance System. Eight years of Pharmaceutical Manufacturing experience with Eli Lilly. Twelve years in R&D Quality at Shire/Takeda and most recent positions with Jazz Pharmaceuticals Heading R&D Audits & Inspections.

Managed and hosted MAH, Supervisory Authority & many local PV system inspections (e.g., UK, EU, China, Saudi Arabia, South Africa, Australia).

Doris I. Stenver, MD, MPA, DK

Pharmacovigilance Adviser / Founder

Unique Advice

Doris Stenver is the founder of Unique Advice, an independent consultancy spe­cialised in pharmacovigilance. Previously she was the chief medical officer of the Danish Medicines Agency. After spending 12 years as a physician at university hospitals, Doris became a specialist in internal medicine. Her research activities and publications were primarily within the areas of hematology, immunology, nephrology and endocrinology. She joined the Danish Medicines Agency in June 1998, initially as senior medical officer. In 2002, she was appointed chief medi­cal officer. She was a member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. From July 2012 until end of February 2019 she was a member of the Pharmacovigilance Risk Assessment Committee (PRAC). Her regulatory experience comprises all aspects of pharmacovigilance, including sci­entific evaluation of drug safety issues, development of risk management strate­gies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public. She’s the author of several international publications on various aspects of pharmaco­vigilance, and she’s an experienced conference speaker and moderator.

Andrea Oliva, IT

Head of Pharmacovigilance

Mylan

Graduated in Milan in Pharmaceutical Biotechnology then graduated in Biology Applied to Biomedical Research. He spent two years as a researcher in the field of infectious diseases at the L. Sacco Hospital. From 2009 He started in the technical/scientific department as deputy QPPV for Teofarma. After a short experience in the regulatory team in DOC Generici, he moved on to consultancy, where he was in charge of coordinating both post-marketing and clinical research activities for pharmacovigilance, also assuming the role of QPPV for various MAHs. In the last period of consultancy experience, Andrea was also in charge of coordinating the Regulatory Affairs office. From 2015 he was responsible for pharmacovigilance for both human and veterinary medicines at Boehringer Ingelheim Italia. Starting from July 2017, he took the role of Head of Pharmacovigilance for Mylan Italia, where he coordinates and manages the pharmacovigilance for drugs, cosmetics, food supplements, and medical devices, including the coordination of medical information activities.

Dr. Max Waschbusch, MD USA

TA Head Cardiovascular and Metabolism Global Clinical Safety and Pharmacovigilance

CSL Behring 

Max Waschbusch is a physician with more than 15 years of clinical practice experience and more than 20 years in the pharmaceutical industry. He is a recognized leader in the cardiovascular and metabolic drug safety development space. He worked for Bristol Myer Squibb, Sanofi, and has lately joined CSL Behring in the role of Head of Cardiovascular and Metabolism in the Clinical Safety and Pharmacovigilance department. He is a member of the American College of Cardiologist and the DIA-ASA BRAT task force. He has been actively involved in the area of Benefit-Risk assessment, signal assessment, and risk management. 

Marie-Laure Kürzinger, FR​

Benefit-Risk Expert ​Global Epidemiology & Benefit-Risk Evaluation ​ ​

Sanofi

Marie-Laure Kürzinger has more than 20 years of experience in Epidemiology. Before joining the pharma industry, Marie-Laure worked in academia where she developed field epidemiology expertise. In 2008, she joined the pharma industry first at Sanofi Pasteur MSD in the vaccine area and then at Sanofi as an Associate Director of Pharmacoepidemiology. Since 2018, she is a benefit-risk expert and leads the development of benefit-risk models for drugs under development but also marketed drugs, and in close collaboration with stakeholders from other functions (e.g. pharmacovigilance, pharmacoepidemiology, medical, regulatory, statistician, clinical operations, affiliates).

Klaudija Marijanovic Barac, HR

Senior Director, Teva Periodic Reports & Risk Management Centre

Teva Pharmaceuticals

Klaudija Marijanovic Barac is a physician with more than 16 years of experience in different aspects of pharmacovigilance and therapeutic areas. She started work­ing in the pharmaceutical industry in 2002, being one of the founders of the Pharmaco­vigilance Department in PLIVA. She was Lead Safety Physician in Barr Group and established RMP Group in Teva in 2015. She also led a project of development of an additional risk minimization implementation tracking tool in Teva. At present, she is Senior Director within TPC. Her team supports marketing authorizations in the EU and international markets for generic, innovative, and biological/biosimilar products. Klaudija is a member of the pharmacovigilance workstream within Medicines for Europe.

Khaudeja Bano MD., USA

Executive Medical Director, Head of Combination and Device Product Safety

Amgen

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).

Aman Wasan, HU

Senior Vice President, Business Development & Client Partners

ArisGlobal

Aman heads the Global Client Partners organization at ArisGlobal. In this role, he is responsible for the commercial as well as the account management strategy for ArisGlobal’s existing customers globally. Aman previously served as Vice President of ArisGlobal’s Safety business unit, allowing him to bring a unique product management perspective to our existing customers. Prior to ArisGlobal, Aman held increasingly senior roles at BioClinica to support large scale safety case processing initiatives for top global life sciences firms.

Mircea Ciuca, CH

Therapeutic Area Head in Global Clinical Safety & Pharmacovigilance

CSL Behring

Mircea Ciuca, MD, is currently Global Therapeutic Area Head (Respiratory & Transplant) in Clinical Safety and Pharmacovigilance department at CSL Behring. He is leading a team of safety physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings.

Mr. Ciuca has about 15 years of experience in drug safety. Prior to joining CSL Behring, he held various positions (Global Head Medical & Clinical Drug Safety, Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large/midsize pharmaceutical companies in The Netherlands and Switzerland, after successfully establishing and leading the medical-scientific department of a medium-sized CRO in Rotterdam.

After graduating from the University of Medicine and Pharmacy in Bucharest, Romania, he became a specialist in Emergency Medicine, and later in Obstetrics & Gynecology. He was involved in clinical practice and academic teaching for about 12 years. Later he has completed postgraduate studies in Pharmacovigilance at the University of Hertfordshire, UK.

Irina Ciubotaru, FR

Deputy EU QPPV

Novartis

Irina is a pharmacist by education, born and raised in Romania. She has started her career in pharmacovigilance and patient safety in 2009 and worked with a variety of regulatory requirements (EU, US, non-EU as well). Had the chance to be part of building up pharmacovigilance systems for small and medium-sized generic or biotech type companies. Now she is based in France, working for the last 3 years in the area of drug safety. Currently in the role of deputy QPPV Novartis with a focus on radioligand therapies.

Melvin S. Munsaka PhD, USA

Senior Director and Head, Safety Statistics

Abbvie

Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences department. He has a PhD in Mathematical Statistics from Queen’s University in Canada and an MSc in Mathematical Statistics and an MEd in Mathematics Teaching from McGill University in Canada. Melvin has been in the pharmaceutical industry for more than 20 years. He co-leads some initiatives of the Drug Information Association Bayesian Scientific Working Group Safety Subteam, the ASA Biopharmaceutical Section Safety Working Group, and the PHUSE Safety Analytics Sub-team. He is also the Publicity Chair of the Midwest Biopharmaceutical Statistics Workshop and has held positions of President, Program Chair, and Chapter Representative of the Northeastern Illinois Chapter of the ASA. He is also a Past Chair of the ASA Section for Statistical Programmers and Analysts and a member-at-large of the Executive Committee of the ASA Biopharmaceutical Section. Melvin is also a lecturer in Biostatistics at the University of Chicago Graham School of Continuing Liberal and Professional Studies. He is a member and Secretary of the Board of Directors of the Chicago Public Schools STEM Program. He continues to take courses in his areas of interest and to explore new ideas related to quantitative analysis and visual analytics of safety data, big data, machine learning, artificial intelligence, neural networks, and natural language processing, especially as to how these apply to patient safety data. He continues to publish papers and present at professional meetings, and performs peer-review journal articles when requested for various journals.

Raj Bhogal, UK

Senior Director, Head of R&D Audits & Inspections

Jazz Pharmaceuticals

Doris I. Stenver, MD, MPA, DK

Pharmacovigilance Adviser / Founder

Unique Advice

Andrea Oliva, IT

Head of Pharmacovigilance

Mylan

Dr. Max Waschbusch, MD USA

TA Head Cardiovascular and Metabolism Global Clinical Safety and Pharmacovigilance

CSL Behring 

Marie-Laure Kürzinger, FR​

Benefit-Risk Expert ​Global Epidemiology & Benefit-Risk Evaluation ​ ​

Sanofi

Klaudija Marijanovic Barac, HR

Senior Director, Teva Periodic Reports & Risk Management Centre

Teva Pharmaceuticals

Khaudeja Bano MD., USA

Executive Medical Director, Head of Combination and Device Product Safety

Amgen

Aman Wasan, HU

Senior Vice President, Business Development & Client Partners

ArisGlobal

Mircea Ciuca, CH

Therapeutic Area Head in Global Clinical Safety & Pharmacovigilance

CSL Behring

Irina Ciubotaru, FR

Deputy EU QPPV

Novartis

Melvin S. Munsaka PhD, USA

Senior Director and Head, Safety Statistics

Abbvie

BROCHURE

Request the 6th Pharmacovigilance & Drug Safety Live Event brochure, and find out the latest topics and ideas that will be shared.

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What our
participants
are saying

5th Pharmacovigilance & Drug Safety Event was a well-organized conference. I have received tips and actionable suggestions on how to implement valuable strategies. Small and intimate — which was great for having worthwhile conversations.

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Jennifer Beutler

Actelion

This conference format is an excellent opportunity for those who are looking for expert pieces of advice and getting exposure to what’s new in the industry on a macro level. It’s also an opportunity to mingle with the industry thought leaders community.

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Attendee

I was pleased by the level of this conference: terrific content and speakers, a great environment, good food, and relevant vendors. A lot of detailed sessions centering around Pharmacovigilance & Regulatory challenges that have given me inspiration for future projects.

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