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6th Pharmacovigilance & Drug Safety

  • 3rd 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

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

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

Founder of Unique Advice

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. 

Raj Bhogal, UK

Senior Director, Head of R&D Audits & Inspections

Jazz Pharmaceuticals

Doris I. Stenver, MD, MPA, DK

Founder of Unique Advice

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 

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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Previous

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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Previous

Attendee