A unique opportunity to engage in the sharing of good practices between industry representatives and seek the advice you need from regulators.
DIA has a long history of working closely with Industry and Regulators to bring topics and speakers together with broad audiences in order to create stimulating and relevant discussion.Join the DIA Pharmacovigilance Strategy Workshop to discuss the current landscape and join intense and well-lead discussion that may help you to progress your knowledge and practices.
The workshop format is designed to stimulate dialogue and generate solutions through a series of interactive sessions and workshops conducted in an informal setting allowing for in-depth discussion in smaller groups.On the 5th Anniversary, the committee and DIA team has put together an agenda with cutting-edge topics which will instigate to open dialogue around:
- Current regional and global regulatory landscape;
- Sharing experience from generic companies around the Risk Management Plan: creation and challenges;
- The pharmacovigilance impact and strategy for vaccines, biologics and therapeutics;
- Utilization of Digital Health and what implementation means for safety in the clinical and post-market space;
- Remote Inspections and Audits: lessons learnt.
NEW in 2021: DIA Pharmacovigilance HackathonForming teams around a hot topic in pharmacovigilance and using a facilitated design-thinking framework to identify concrete next steps and possibly answers to these important questions. Each team will be pre-formed as a multi-stakeholder unit, in order to promote an impartial dicsussion. Participants will benefit from each other's different backgrounds as a strong driver for lateral thinking and creative problem-solving with some of the brightest minds in the life sciences field.
- The Future of Pharmacovigilance: What to Keep/Change?
More information on the registration to be divulged soon.
- Seek direct answers to the business challenges you are facing every day
- Understand how other organisations are managing through the shift of sharing all information to sharing relevant information
- Understand the regulators expectations for signal assessment, risk management planning, and risk communication
- Ensure that your pharmacovigilance work matches up with inspector expectations and delivers the efficient outcomes for patients.
- Pharmacovigilance Guidelines and Regulations Updates (EU, non-EU, Global)
- Pharmacovigilance Changes in the UK
- Harmonisation of Additional Risk Minimization Measures and Pharmacovigilance Activities
- Risk Management and Communication for Vaccines. Biotherapeutics Impact of COVID-19 Pandemic
- Impact of Digital Health and How it is Managed. What Medical Device Regulation Means For Pharmacovigilance
- Remote Inspections & Audits: Lessons learnt
Who should attend?
Established professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current regulatory views and gain practical knowledge in key areas in pharmacovigilance, including:
- Signal management
- Data Privacy
- Risk Management Planning
- PSMF maintenance
- Clinical Trials
Professionals involved in:
- Drug Safety/Pharmacovigilance
- Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
- Benefit-risk assessment and communication
- Medical Product Safety Assessment
- Regulatory Affairs
- Clinical Trials
- Pharmaceuticals, biologics, combination products, devices
- Clinical Research and Clinical Research Organizations
- Health Outcomes
- Academic Research Centers
- Regulatory Agencies
FRANCOISE SILLAN, MD • VP GPS TA ENDO-ONCO & EU QPPV
Wendy Huisman, PharmD • Director
Shahin Kauser • Lead Scientific Assessor
MHRA, United Kingdom
Maarten Lagendijk, MSc • EU QPPV Deputy
Merck Sharp + Dohme B.V., Netherlands
Bianca Mulder, PharmD, MPharm, MSc • Pharmacovigilance Assessor
Medicines Evaluation Board, Netherlands
Giovanna Rizzetto • Senior Manager, Regulatory, Drug development and Manufacturing
Willemijn van der Spuij, MSc • Exec. Director International World Wide Patient Safety, Europe
Bristol-Myers Squibb, Switzerland
James Whitehead, MSc • Patient Safety Medical Device Lead
Astrazeneca, United Kingdom
Elena Popa, MPharm • Senior Manager, Scientific Programs
Drug Information Association (DIA), Switzerland