Journal of Pharmacovigilance

Stakeholder′s engagement strategy in healthcare industry - Safety prospective

10^th Pharmacovigilance Congress

September 20-21, 2017 Charlotte, USA

Essam Ghanem

Keyrus Biopharma, Belgium

Keynote: J Pharmacovigil

Abstract:

During drug development process, regulators, pharmaceuticals, consumers, patientsâ?? representing groups and health care professionals â??partnership has a considerable challenging impact in healthcare industry. Accordingly, the health authorities Liaison with stakeholders such as patientsâ?? representing groups and health care professionals, emphasizing their role in medicines risk assessment. This speaks for considerable challenging impact of consumers, patients and patientsâ?? representing groups on public health protection. Visibility of such partnership necessitates the presence of effective action plan that enhances such stakeholdersâ?? interfaces which is still missing at present stage. The regulators together with pharmaceuticals should make the necessary effort for better patientsâ?? involvement by understanding their requirements and monitoring their responses. In that sense, the interactive engagement modelling and relevant guiding regulation Implementation that facilitates patientsâ?? anticipation is an inevitable requirement. Effective stakeholdersâ?? engagement has crucial impact on pharmaceuticals drug development for favorable outcomes and it will be valuable in drug regulators decision-making process throughout the medicine product life cycle.

Biography :

Essam Ghanem is an experienced Physician and Qualified Person for Pharmacovigilance with almost 25 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Clinical Research Organizations. He has around 8 years of working experience as EUQPPV and as Consultant Safety Physician in the Pharmaceutical Industry. He is the Founder of the pharmacovigilance consultation company Vigi-Care BVBA. Presently, he is the Head of Drug Safety and Pharmacovigilance at Keyrus Biopharma (BE, FR, CA, LEB) and is the Membership Owner of European Society of CRO Federation (EUCROF).