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Pharmacovigilance Risk-benefit optimisation … November 2010 Pharmacovigilance Regulatory Science...

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www.pharminvent.com November 2010 Pharmacovigilance Regulatory Science Risk Management Risk-benefit optimisation Advanced Therapies Biologics Biosimilars Generics Small molecules Centrally authorised Decentralised procedures Mutually recognised Nationally authorised

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Page 1: Pharmacovigilance Risk-benefit optimisation … November 2010 Pharmacovigilance Regulatory Science Risk Management Risk-benefit optimisation Advanced Therapies Biologics ... November

www.pharminvent.com November2010

Pharmacovigilance

Regulatory Science

Risk Management

Risk-benefit optimisation

Advanced Therapies

Biologics

Biosimilars

Generics

Small molecules

Centrally authorised

Decentralised procedures

Mutually recognised

Nationally authorised

Page 2: Pharmacovigilance Risk-benefit optimisation … November 2010 Pharmacovigilance Regulatory Science Risk Management Risk-benefit optimisation Advanced Therapies Biologics ... November

www.pharminvent.com November2010

PharmInvent is led by experienced

EU ex-regulators, including former

members of CHMP and PhVWP, EMA

managers, as well as ICH and CIOMS

expert group members.

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