6 Challenges to Safety Risk Management - Roche

Philippe Van der Auwera
Posted: 06/13/2011

According to Prof. Philippe Van der Auwera, Global Head of Safety Risk Management (PDS) & EU QPPV at F.Hoffmann-La Roche Ltd, the 6 key challenges to Safety Risk Management stem from Data, Communication, Organisation, Talent, Money and Strategy.

He shares his insights in this exclusive interview with Pharma IQ’s Charis Jiang, where he highlights the importance of safety risk management over pharmacovigilance, saying “the term Pharmacovigilance is used in an ambiguous way, I prefer to use the expression "Safety Risk Management” as it covers all aspects of safety from before entry into human to divestment from the market” and the 4 processes in safety, i.e.: single case processing, integrated signal detection & assessment, integrated safety management and comparative benefit risk assessment.

Read the full interview below:

Pharma IQ: A number of people define PV as strictly post-market. Do you think so too?

Dr. Philippe Van der Auwera: The term PV is used in an ambiguous way, this is why our function is called “Safety Risk Management”, and it covers all aspects of safety from before entry into human to divestment from the market. There are plenty of good examples of excellent risk management at each company. The real issue is the rare high-visibility situations with dramatic outcomes, including GSK’s Avandia, and Mediator from Servier in France.

Pharma IQ: What’s the relation between Pharmacovigilance and Safety Risk Management departments?

Dr. Philippe Van der Auwera: For us, safety risk management covers everything including PV, which in its restrictive meaning, covers post-marketing safety only. “Safety Risk Management” covers all aspects of safety from before entry into human to divestment from the market and the 4 processes in Safety, ie: single case processing, integrated signal detection & assessment, integrated safety
management and comparative benefit risk assessment.

Pharma IQ: Is data acquisition, management and analysis a significant area in pharmacovigilance?

Dr. Philippe Van der Auwera: Safety data have a variety of origin, robustness and format (clinical studies, spontaneous sources, social media, medical & scientific literature, and preclinical studies). They must be integrated to support safety signal detection & assessment. The growing use of meta-analyses (e.g. erythropoietins & Avandia meta-analyses leading to REMS with ETASU) is imposing a proactive approach to running clinical studies ensuring that the data can be used later on for metaanalyses. This requires discipline across the world of Affiliates (sponsored and supported studies) and resources (warehousing the data to enable metaanalyiss)

Pharma IQ: Besides data management, what are the other challenges to Safety Risk Management?

Dr. Philippe Van der Auwera: In my view, the other challenges include communication, organisational, talent, money and strategic challenges.

Pharma IQ: Why do you see communications as a challenge?

Dr. Philippe Van der Auwera: Labels, patients information leaflets, dear doctor letters and risk management plans have limited effectiveness in their role of ensuring safe use of medicines. Media and lawyers are also playing a growing role. Right now,  Marketing departments are unlikely to get excited about this, but they will be in the future. We need to work together with Health Authorities, patients, doctors and academia to work on better communication and test their impact on comprehension but also and most importantly behaviors.

Pharma IQ: You also highlight organisational challenges. What do you mean?

Dr. Philippe Van der Auwera: Clinical Safety is moving from a tactical reactive role with limited influence to a major strategic role throughout the product life cycle. This requires organisational changes & strong governance. At the Pharmacovigilance Asia 2011 conference, I’m looking forward to a round table to see the variety of organisational (reporting lines) and governance models and compare best
practices.

Pharma IQ: What are the other departments that are increasingly involved in risk management and PV?

Dr. Philippe Van der Auwera: The departments include Clinical, Regulatory, Compliance, Corporate Sustainability & Risk Management, Medical Affairs (head office and affiliates) and top management.

Pharma IQ: You’ve put down ‘talent’ as a challenge. Why do you say this?

Dr. Philippe Van der Auwera: The profile of clinical safety staff is changing dramatically in all aspects be it Safety Operations, Safety Science or Compliance & Business Processes, and making the role very challenging. While we have strong change management support in my leadership team, we occasionally use other external resources to address this challenge.

Pharma IQ: Now let’s come to the dollars and cents. Are budget constraints a challenge?

Dr. Philippe Van der Auwera: Budgets allocated to clinical safety is not growing in parallel to the dramatic increase in data flow (20% per year) and growing complexity of the work (proactive safety risk management in an integrated way). This requires major strategic and tactical changes. This is linked to the organization model. Usually the org resists any increase in budget for safety risk management unless there is a product catastrophe. There are however interesting trends in strategic outsourcing, tactical outsourcing and moving staff to more cost-effective places (India or China, or other places) that are helping us to work with the budget constraints.

Pharma IQ: When you talk about strategic challenges, what do you mean?

Dr. Philippe Van der Auwera: Patients and treating physicians/academics have been kept away from the regulatory process leading to a loss of credibility of the industry and the regulators among citizens. Going forward more engagement will be necessary to manage the safety risks.

Dr. Philippe Van der Auwera is part of the expert panel addressing the upcoming Pharmacovigilance Asia 2011 conference, meeting in Singapore from 17-20 October 2011.

Philippe Van der Auwera
Posted: 06/13/2011

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