Registration and Morning Coffee

Opening Remarks From The Organizer and Chair

Ice-Breaking and Networking Activity

PV Agreements Process Optimization

Valentina Mancini

• Managing the end-to-end process, from due diligence to termination
• Engaging stakeholders
• Negotiating with business partners and integrating processes
• Monitoring performance
• Training

Valentina Mancini

Senior Director Pharmacovigilance, QPPV

Shionogi

Additional Risk Minimization Measures

Dr. Dnyaneshwar Sanap

• Basics of risk minimization in Pharmacovigilance
• Routine Vs additional RM measures
• Planning, implementing aRMMs including measuring effectiveness
• Learning lessons and tips

Dr. Dnyaneshwar Sanap

EU/UK QPPV, Head Regional Pharmacovigilance

Glenmark Pharmaceuticals

Coffee-Break

Signal Detection – Generic Industry perspective

Mohamed Ali Kotal

Generic companies frequently face challenges on signal management, which may impact updates to product information related to safety concerns especially when these originate externally. 

Competent authorities expectations are similar for innovative and generic marketing authorization holders in respect to the signal management. Based on the regulations and information received from the authorities “sufficient evidence” is needed for safety variations for Generics, as well as for the innovative products.  

However, in practice signals submitted by the generic MAH many a times face rejection or placed on hold on the grounds of “insufficient evidence”, in particular when the reference product label doesn’t include the respective safety topic.

Learn from Mohamed Ali Kotal, Head Medical Safety at Sandoz, speaking at the 3rd Pharmacovigilance & Drug Safety Conference in Lisbon on 6 & 7 June.

Mohamed Ali Kotal

Head Medical Safety

Sandoz

Challenges in Consumer Healthcare Safety

Agnieszka Kicman-Gawłowska

Within a portfolio of over-the-counter (OTC) medicinal products and medical devices, cosmetic products, and dietary and food supplements, Consumer Safety needs to be flexible and adaptable to different regulatory requirements globally and meet quality and compliance expectations of Health Authorities globally. In recent years more activity in regulatory framework globally was observed in medical device and cosmetic areas. A lack of harmonization in global regulations requirements is observed in cosmetic products.

- Regulatory framework in different types of consumer healthcare products
- Proposal of best practice in approach to prepare and implement new regulatory requirements in a global Consumer Safety

Agnieszka Kicman-Gawłowska

Associate Director, Consumer Safety Science

Haleon

Roundtable Discussion

All delegates will have 30 minutes to discuss
trending topics in the Pharmacovigilance field.

Lunch

Patient Involvement for Better PV Knowledge - Driving Patient Centricity Through Your PV Project

Yvonne Nanciu

Patients need to play a crucial role in the decision-making regarding their own disease treatment and therapy options. However, their knowledge of Pharmacovigilance (PV) aspects is still quite limited despite the industry´s effort to make the science of Pharmacovigilance and the importance of adverse event reporting more popular - and palatable. What I am hoping through this presentation is to share from our experience, and have an open discussion about what can we do differently/better to reach our patients, putting their safety first.

- The importance of patient-centricity as the main driver of PV activities
- Aspects to consider when setting up a Patient Support Program
- What can we do with limited budget to reach our patients
- Is there a specific PV time to shine during the year? Highlights from last year´s Patient Safety Day and Med Safety Week
- Open discussion and exchange of ideas

Yvonne Nanciu

PVCH Germany, Deputy EU QPPV

Bayer

Overview of Signal Detection and Challenge During Pandemic

Maria Maddalena Lino

A safety signal is defined as information suggesting a new potential association or new aspects of a known association between medicines and adverse reaction(s) that warrant further investigation. The way a safety signal is detected and evaluated changed a lot during the last years. Different methods can be used, such as quantitative and qualitative analyses, clinical trial data review, medical literature review and epidemiology-based analyses such as observed vs expected analysis. Each of them has caveats and advantages to be considered and while they could be used alone their results may not be reliable as when they are used together to evaluate a signal. During the last two global pandemics (H1N1 and COVID-19), the pharmacovigilance world changed extensively to adapt and meet unprecedented needs. Literature review and observed vs expected analysis played a key role in signals evaluation. Various alternative sources of signals, such as social media monitoring have been explored for the Covid-19 vaccines worldwide. The COVID-19 vaccines were subjects of an unprecedented level of pharmacovigilance implemented by the MAHs, regulatory authorities and public health organizations. This and the increased level of communication about safety data between the MAHs and regulatory authorities, helped to turn the pandemic into an opportunity to make important steps forward in the pharmacovigilance area.

Maria Maddalena Lino

Safety Risk Lead Director

Pfizer

Coffee-Break

The Application of AI for the Detection of Adverse Events

Richard Hughes

Learn from Richard Hughes, Global Head of Patient Safety and Pharmacovigilance, Biogen, speaking at the 3rd Pharmacovigilance & Drug Safety Conference in Lisbon on 6 & 7 June.

Richard Hughes

Global Head of Patient Safety and Pharmacovigilance

Biogen

Why Oncology Global Patient Safety Teams Should Develop the Safety Section of the Study's Target Product Profile?

Michael Kieffer

Oncology Global Safety Teams (GSTs) are usually not tasked with the development of the risk section of the products Target Product Profile (TPP). This fact makes little sense since the GST is tasked by the company to identify, analyze, and mitigate a product's risks. The TPP, in essence, establishes boundaries for go-no-go decisions around a product or products in combination treatment. Involvement of the Oncology GST in
producing a well-researched and evidenced-based TPP safety section allows the team to develop knowledge around the drug(s) studied or added to a study arm. The increased use of umbrella and platform studies for early-phase oncology trials allows an excellent resource for the use of clinical data to estimate the risk of developmental drugs combined to treat a given oncology indication. To shorten the time to marketing, companies are including developmental products with novel mechanisms early within their development
cycles. Antibody Drug Conjugates (ADCs) and Bi-Directional Antibodies are a few examples of products combined in arms of a platform or umbrella study early and with only immature clinical data available. This talk will share a novel analytical approach for safety teams to develop a well-thought-out and defendable safety section for the TPP. Strategies to estimate the risks associated with combination therapies will be
brought forward. The advantages of having the safety team involved early in the benefit/risk, go-no-go decisions for a study, or the addition of a study arm will be detailed. The early development of a well-documented TPP will enhance chances of a successful product submission.

*The existing framework for most companies' TPP development does not include GST input for the safety section.

*GSTs have the required skill set to provide the product risk analysis necessary to produce an effective estimate of risks for the safety section of the TPP.

*This talk provides a new framework to include GSTs in the TPP development and methods for the GSTs to meet this new requirement.

Michael E. Kieffer

President

Focused Consulting, Staffing, & Drug Safety, LLC

Roundtable Discussion

Panel Discussion: Navigating the Complexities of Drug Safety in the Digital Age

Corina Mangu

• Discuss the role of real-world data in pharmacovigilance and its impact on drug safety assessments
• Explore opportunities for leveraging digital health data for proactive adverse event monitoring and patient-reported outcomes
• Examine ethical dilemmas related to pharmacovigilance, including issues of patient privacy, informed consent, and the balance between public health surveillance and individual rights
• Examine how AI and ML technologies are transforming pharmacovigilance processes, including adverse event detection, signal detection, and risk assessment

Cocktail Reception