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Pharmacovigilance Services

Enhancing Drug Safety and Patient Care Through Specialized Pharmacovigilance Expertise

BOOK 1 HOUR FREE SCOPING SESSION

Defining & Operationalizing your medical affairs value proposition

Understanding your needs and scoping the assignment.

Risposta Consulting offers you the benefits of our significant pharmacovigilance experience.

Book a free call with us to explore your options !

møde

PV Regulatory Advice &
Risk Assessment

Ad Hoc advice related to interactions with regulatory bodies and conduct of risk assessments.

møde

Interactions with Regulatory Agencies & Experts

Preparation & execution of safety related meetings with agencies and experts.

Bogholder

Safety Review of Study Protocols

Ensuring compliance with PV requirements

Mikrofon

PV Communication

Safety review of communication, reports or publications. Preparation of presentations, reports, facilitation of expert meetings etc.

Dr. Hans Chr. Siersted, born in 1956, is a seasoned medical professional, certified specialist in pulmonary diseases, allergology, and medical education. A graduate of Odense University, Denmark, he has an impressive career spanning clinical practice, academia, and regulatory consulting.

 

Dr. Siersted leverages his expertise in pulmonary medicine, gained through significant roles in Danish universities and hospitals, including as Head of Pulmonary Medicine at both Roskilde and Odense University Hospitals.

 

He also served as a Nordic Cluster Medical Lead for GSK and a Chief Medical Officer at the Danish Medicines Agency.

Most recently, he served for almost 5 years at the Danish Medicines Agency, supervising regulatory post-marketing procedures for a multitude of products on the European level. As a national delegate and rapporteur in EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) he gained deep insights in EMA’s procedures, strategies and ways-of-working and developed close professional relationships with representatives from EMA and delegations from Medicines Agencies in Europe and beyond.

Known for his ethical integrity and empathic approach, Dr. Siersted has contributed significantly to medical boards and societies.

He is an active researcher with an H-index of 22 and has engaged in multiple collaborations with the medical industry.

Contact Risposta Consulting

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