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Home / Making Clinical Trial Safety and Pharmacovigilance easy and affordable with HALOPV

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Making Clinical Trial Safety and Pharmacovigilance easy and affordable with HALOPV

Zoom webinar

Did you miss our live webinar? Get access here.

LINK Medical & Insife have created a partnership to offer easy and affordable clinical trial safety and pharmacovigilance solutions. In this webinar, you will learn how HALOPV, a sophisticated safety toolkit helps biotech and pharma companies manage their clinical trial safety and pharmacovigilance activities in a simple and cost-effective way. Modules are available to cover all data and processes. You can start with the safety database modules and slowly add to your suite of modules until you have a full pharmacovigilance system.

You will hear from Martin Holm-Petersen CEO of Insife and also Tina Elberling, International Safety Director, and Ewa Lyzell, Safety Group Manager, at LINK Medical. The seminar will have an overview of how the concept of a database is transforming into a flexible model, and how HALOPV can be a solution for all biotech and pharma companies – large or small.

More on HALOPV

PV technology used to be extremely resource-intensive for pharma companies to implement and maintain – and very expensive for smaller biotech’s and pharma companies. As a result, many companies are relying on spreadsheets and emails for maintaining compliant clinical trial safety and pharmacovigilance operations. HALOPV can process, track and audit all your deliverables with less effort, freeing up time and resources to focus on the value-adding activities.

HALOPV is a PV toolkit that helps pharma companies manage their clinical trial safety and pharmacovigilance activities. Modules are available to cover all data and processes: ICSRs, Submissions, Aggregate Reporting, Entities, Products, Clinical Studies, Risks, PSMF Management, Signals, Literature, Product Complaints, Medical Information, Data Collection Programs, Quality Management, Requirements Intelligence and Device Vigilance.

To meet expectations of the digital era, HALOPV is cloud based and has a wide range of features for automation such as artificial intelligence and integrations. The software is intended to maximise productivity, while being easy to put in place.

Agenda:

14:00 Introduction and welcome!

14:03  Partnership and commercial frame for potential customers – by Tina Elberling

14:15 Short presentation of HALOPV and its modules – by Martin Holm-Petersen

14:45 How HALOPV will change the way we work and support our customers- by Ewa Lyzell

14:55 Conclusion/Q&A

Speakers:

Tina Elberling

Safety Director, LINK Medical
Tina holds both an MD and a Ph.D. from Copenhagen University. In addition to residential and medical internship positions, she has conducted both pre-clinical and clinical research within the fields of cerebral blood flow auto-regulation and psychoneuroendocrinology. She has also worked as a sub-investigator in clinical phase I-IV trials at the Danish Dementia Research Center. Tina has more than 15 years of experience within the pharmaceutical industry, mainly with clinical trial safety and pharmacovigilance, and has extensive experience working with some of the best known safety databases. Prior to joining LINK Medical in August 2020 as head of International Safety Operations, Tina worked as a GVP inspector at the Danish Medicines Agency.

Ewa Lyzell

Safety Group Manager, LINK Medical
Ewa is a registered nurse in Sweden and holds a BSc in Medical Science from the University in Lund. After a few years working within the radiation therapy field, she started working in the pharmaceutical industry holding various positions in the field of pharmacovigilance. Since then, she has worked with clinical trial safety and pharmacovigilance for more than 25 years. Ewa has international experience working for pharmaceutical companies in Sweden, Denmark and the US. In addition to her role as Group Manager for the Safety Operations team in Sweden, Ewa also holds the position of EU Qualified Person responsible for Pharmacovigilance (EU QPPV). 

Martin Holm-Petersen

CEO, Insife
Executive leader with 10 years of experience within the pharma industry and another 10+ years in consulting. Martin is an experienced manager and strategist, with understanding across the pharma business value chain, and an expert on Pharmacovigilance. His current role is CEO of Insife, a global consulting and technology company. In this capacity, digital transformation is central to Martin’s engagements with Industry and Regulatory Agencies. In his previous role, he headed the pvtech global industry pharmacovigilance technology network with more than half of top 100 pharma participating.

 

Answering Question before the webinar:

 

Did you miss our live webinar? Get access here.

 

 

 

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