Tag: Events

Geriatric Pharmacovigilance and Benzodiazepenes

By Joan D’Souza

Regulatory Affairs Professional

In this webinar, Joan D’Souza, a regulatory affairs professional based in Switzerland, will continue last month’s discussion of geriatric pharmacovigilance. Her presentation will focus on the dangers and management of benzodiazepenes in older adults.

The webinar is open to all and will be of interest to any medical writers interested in learning more about regulatory affairs.

We look forward to seeing you there!

Geriatric Pharmacovigilance

By Joan D’Souza

Regulatory Affairs Professional

In this webinar, Joan D’Souza, a regulatory expert based in Switzerland, will discuss geriatric pharmacovigilence. We invite you all to learn the negative consequences related to the use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and Antibiotics in the Geriatric Population.

The webinar is open to all and will be of interest to any medical writers interested in learning more about EU regulatory writing.

We look forward to seeing you there!

Risk Minimisation Measures in EU Pharmacovigilance

By Joan D’Souza

Regulatory Affairs Professional

In this webinar, Joan D’Souza, a regulatory expert based in Switzerland, will discuss EU risk minimization measures used to prevent or reduce adverse drug reactions, how various risk minimization tools are selected, and how they are evaluated to assess their effectiveness.

The webinar is open to all and will be of interest to any medical writers interested in learning more about EU regulatory writing.

We look forward to seeing you there!

Risk Management Plan (RMP) with Safety communication and Risk Minimisation Measures (RMM)

By Joan D’Souza

Regulatory Affairs Professional

In this webinar, Joan D’Souza, a regulatory expert based in Switzerland, will be highlighting the key requirements of risk management plans and risk minimization measures in the context of EU regulations.

The webinar is open to all and will be of interest to any medical writers interested in learning more about EU regulatory writing.

We look forward to seeing you there!

GVP Module V (RMP)

By Joan D’Souza

Regulatory Affairs Professional

In this webinar, we will be discussing Good Pharmacovigilience Practices (GVP) for creating a Risk Management Plans (RMP) as part of a new drug application for the European Medicines Agency. The webinar is open to all and will be of interest to anyone starting or contemplating a career in regulatory medical writing.

We look forward to seeing you there!

Body of Writing

By Alexandra Howson, MA, PhD (she/her/hers)

Owner of Thistle Editorial, LLC, and Certified Healthcare CPD Professional

We earn our livings as writers. But how can we maintain the functionality of our bodies and minds to ensure longevity? Writing often involves long sessions at the computer, which can tighten pectoral muscles, restrict breathing, and contribute to shoulder, arm, and wrist discomfort and damage. If you are a writer, you know! This session will introduce specific movement, breath awareness, and myofascial release techniques to strengthen and relieve tension in the writer’s body. Come prepared to participate and leave with tools you can use immediately.

The webinar is open to all. We look forward to seeing you there!

RSVP here to get a link to the webinar: http://evite.me/ArE2HAGmr6

Introduction to RMP and PSUR

By Joan D’Souza

Regulatory Affairs Professional

In this webinar, we will be discussing Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs). These are important documents required for all new drug applications within the European Medicines Agency. Webinar attendees can expect to get a broad introduction to these documents. The webinar is open to all and will be of interest to anyone starting or contemplating a career in regulatory medical writing.

We look forward to seeing you there!