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DIA Workshop on Benefit-Risk Strategy


Thursday, June 15, 2017 - Friday, June 16, 2017
Grand Majestic Plaza, Truhl√°rsk√° 16, Czech Republic
Prague 1, Czech Republic

https://go.evvnt.com/131261-0

Event Type: Conference

 

Are you aware of the key developments on the benefit-risk guidelines?Benefit-risk guidelines continue to evolve with the EMA publishing guidance revisions as recently as this March. This workshop provides you the tools to address these changes by giving you:- Overview of benefit-risk assessments- Examples of challenges and solutions across different departments- Impacts and interpretations of the new guidelinesEMA experts join this workshop to give you tangible insights and tips to navigate the evolving benefit-risk guidelines. The hands-on workshop structure provides you with real-world examples from regulatory and industry perspectives, and explores tangible ways to improve your best practices.Who should attend?Professionals involved in benefit-risk strategy from various departments, e.g. pharmacovigilance, regulatory, clinical, drug safety, medical affairs, or medical writing.Program leads who oversee the clinical development, dossier preparation, and post-marketing phases of the medicines life cycle.Learning objectives - What will you gain?New benefit-risk regulations call for a more structured and formalised process. This workshop will:- Increase your understanding of the current benefit and risk landscape- Empower you to perform benefit-risk management more effectively within your organisation- Create a toolkit for you to address tactical components of risk assessments, including data collection and digital innovation

 

Are you aware of the key developments on the benefit-risk guidelines?

 

Benefit-risk guidelines continue to evolve with the EMA publishing guidance revisions as recently as this March. This workshop provides you the tools to address these changes by giving you:

 

- Overview of benefit-risk assessments

- Examples of challenges and solutions across different departments

- Impacts and interpretations of the new guidelines

 

EMA experts join this workshop to give you tangible insights and tips to navigate the evolving benefit-risk guidelines. The hands-on workshop structure provides you with real-world examples from regulatory and industry perspectives, and explores tangible ways to improve your best practices.

 

Who should attend?

Professionals involved in benefit-risk strategy from various departments, e.g. pharmacovigilance, regulatory, clinical, drug safety, medical affairs, or medical writing.

 

Program leads who oversee the clinical development, dossier preparation, and post-marketing phases of the medicines life cycle.

 

Learning objectives - What will you gain?

 

New benefit-risk regulations call for a more structured and formalised process. This workshop will:

 

- Increase your understanding of the current benefit and risk landscape

- Empower you to perform benefit-risk management more effectively within your organisation

- Create a toolkit for you to address tactical components of risk assessments, including data collection and digital innovation

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