On-Demand Webinar | What's New in Draft MHPD Guidance on Reporting Adverse Reactions for Marketed Products

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Certus PV, a Veristat Company experts recently lead an Xtalks webinar - View it On-Demand Now

Since the MHPD guidance Reporting Adverse Reactions to Marketed Health Products was last published in 2018, Health Canada has identified several elements of the guidance that require updates to further clarify adverse reaction reporting requirements. Consequently, draft guidance was issued in January 2021 for consultation. This consultation is looking for feedback on the proposed updates to ensure they are clear and relevant and support understanding of the regulatory reporting requirements for the industry. 

 

Join our experts to learn about the changes and implications of the updated MHPD draft guidance.  

 


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Meet the Speakers

 

Anna Bussel_headshotAnna Bussel, PV & MI Manager, Certus PV

Anna Bussel is a Pharmacovigilance and Medical Information Manager at Certus PV, a Veristat Company. She holds a Master’s Degree in Pharmacy and has over 10 years of experience in Pharmacovigilance, Regulatory Affairs and Product Quality from Europe, Canada, and the US. Anna’s pharmacovigilance expertise includes medical assessments of Individual Case Safety Reports, aggregate report preparation, screening and processing of the Canada Vigilance Adverse Reaction Online Database, literature screening, compliance management, and GVP auditing.

 

Elisabete Rego_ photoElisabete Rego, PV & MI Manager, Certus PV

Elisabete Rego is a Pharmacovigilance and Medical Information Manager at Certus PV, a Veristat Company. She holds a Master’s degree in Biomedical Sciences. Elisabete is an accomplished bilingual Pharmacovigilance and Medical Information professional with over 6 years of experience in the industry combined with extensive scientific knowledge in several therapeutic areas. Elisabete leads complex Pharmacovigilance and Medical Information projects while ensuring regulatory and contractual compliance.

 

 


 

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