Overview From the idea to the patient Since 1231, when Friederich II passed the Constitutione Regni Siciliae, (the first medicinal law for Europe) the regulations for medicinal products have changed. The first chemically synthesized APIs in combination with the industrialization beginning 1900, shifted the production of medicinal products [...]
Overview The training course will support you in collecting, sorting and proper understanding of the requirements of the serialisation Requirements in Brazil, Russia, in Europe, the US and other markets. This includes the relevant information related to the Brazilian Serialisation, the Russian Crypto Coding, the defined two EU-safety [...]
Overview The Virtual Leadership in Safety workshop is based upon our multi-award winning Leadership programme, reconfigured to meet the needs of business as a consequence of the Global Coronavirus Pandemic. The virtual workshop takes the lessons and tools shared within our ‘classical’ classroom workshop environment and reinterprets them [...]
Key Takeaways The latest outcomes of the effects of COVID19 on the delay of new product launch Can Price Transparency contribute to more affordable patient access to medicines? Reaching a better integration of regulatory pathways A look into the personalized reimbursement system Early Payer Engagement Equal access [...]
Overview In current environment bank profitability is under heavy pressure, especially in Europe. Negative interest rates, flat interest curve, heavy investment needed for digitalization, competition from Fintech... this is leading bank profitability to historically low levels, and valuations are also suffering since several years. In this context, ensuring [...]
Overview Analytical instruments and computerised systems operating in regulated laboratories must be fit for intended use. This is achieved by using a combination of analytical instrument qualification (AIQ) and computerised system validation (CSV). In the current regulatory environment instruments and systems must ensure data integrity and therefore technical [...]
Overview Management is managerial disipline - with specific processes, tools and techniques - whose importance is increasingly recognized in the Pharma Industry, expecially in R&D, Development and Sales Functions or Divisions. Managers are increasingly called upon to improve their Project Management skills, in research/discovery, preclinical and clinical studies, [...]
Overview Do you face challenges to attract or retain talent? An effective L&D strategy will attract and ensure an engaged workforce. An engaged workforce not only goes the extra mile or recommends others to join your company, they are also constantly improving their competencies. If L&D Management can [...]
Overview Hazard identification and risk assessment plays a pivotal role regarding managing risks associated with workplace and process safety. They form the foundation for process safety management activities. Once hazards have been identified and associated risks assessed, the acceptability of the risk can be judged. It is critical [...]
The audit has finished. Now is time to put it right in writing. And for some reason, although this step is the most important -in most cases-, auditors fail to do it right. The top mistakes detected: a) The vocabulary is too technical, not clear or the abbreviations used are excessive. Example: “The observation is [...]
