Draft MHPD Guidance “Reporting Adverse Reactions to Marketed Health Products”- What’s New?

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 Consequently, a draft guidance was issued in January 2021 for consultation.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 industry. The consultation period closes on 25 April 2021. Join our experts to learn about the changes and implications of the updated MHPD draft guidance.  Come prepared to ask questions to the speakers and to Certus PV founding  partners Agnes Jankowicz, M.Sc., Vice President of Pharmacovigilance and Rita Cassola, B.Pharm. (Hons.), Vice President of Pharmacovigilance.

Speakers

Anna 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.

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Elisabete 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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