Post-Market

Regulatory bodies such as the FDA and EMEA are intensifying safety regulations, thereby boosting the adoption rates of pharmacovigilance systems by pharmaceutical companies. As a pharmacovigilance professional you need to:

• Stay informed and adhere to continually changing reporting regulations and trends
• File for final new drug approval (NDA)
• Monitor and track all adverse events for early and complete detection of any and all adverse effects (signaling)
• Communicate scientific information, i.e. launch communications, to a range of internal & external audiences
• Prepare and update drug information leaflets/inserts of your products, as well as tracking of competitor products
• Answering questions on own products from health professionals

Embase can help you:

• Track all the published /peer-reviewed biomedical information on your products and quickly review side effects reported for your product
• Compare the therapeutic effects of 2 or more substances on a disease
• Look up reported economic evaluations of specific drug therapies or disease management
• Track a specific drug trade name or names in the literature
• Retrieve necessary information needed to comply with legislation and regulations
• Regulatory filing documentation such as New Drug Application (NDA)
• Clinical trial program management, including protocol and study report writing
• Stay up to date on relevant information with the email alerts and RSS feed

To Learn how Embase Supports the Post-Market Team, contact us today