Pillar 2: Life Cycle Management

Our services for Quality & Compliance:

- CMC Pre and Postapproval
- Quality Systems Consulting and Operational Quality Assurance
- Audits and Inspection Readiness
- Management of Compliance

Our services for vigilance & Safety:EU QPPV and LPPV/LSO
Pharmacovigilance Consulting
Case Management
Regulatory Medical Writing
Medical Information
Literature Watch
Cosmetovigilance
Medical Devices and IVD Vigilance

Throughout CPHI North America 2023, several Breakfast Sessions were held to start the day off right with a complimentary breakfast and a networking and learning session for our attendees. With insightful presentations from industry experts and partners, the CPHI North America Breakfast Sessions had something for everyone looking to fill their brains and their stomachs.    

There seems to be a lack of clarity about the meaning of terms such as “artificial intelligence (AI)”, “machine learning (ML)”, “data science (DS)” and “office automation (OA)”, which should not be used interchangeably. Pharmacovigilance (PV) represents a very interesting field in this regard, since it poses some unique technical challenges. For example, the “signal to noise ratio” and the “quality of the information” are very different in reports from clinical trials and in information coming from social networks, smartphone apps or smartwatches, and therefore require different approaches. Case processing, moreover, requires a mix of administrative and repetitive tasks (e.g. data cleaning and form filling) and tasks that require a high level of experience and specialization (e.g. medical reviews and signal detection). For more information, contact us.