Training

Although businesses have been impacted in various ways, in recent years, nothing should disrupt your team’s ability to expand the knowledge needed to perform their roles even better.

Training is one of the pillars of development that should not be neglected, neither for companies nor for employees. Both parties benefit, as the company achieves improved performance, and employees can develop, refine and update their skills.
Global Regulatory frameworks for Drugs, Cosmetics, Medical Devices and Food Supplements are continuously evolving. A comprehensive understanding of the regulatory requirements plays a key role in providing a successful access to the market.

Guidance is important for businesses. Whether through basic rules or more tailored training, there are offers to meet needs at all levels, from introductory courses on drug and cosmetic product development regulations to specialised topics (e.g., the Early Access Programs in France and other EU Member States, required responsible persons for certain areas of activity, etc.).On one side, having an in-depth knowledge of Global Regulatory, Pharmacovigilance, Global Development and Project Management in those areas would provide added value during the decision-making processes.
On the other side, it is a legal requirement that e.g Pharmacovigilance professionals are trained in the regulations and best practices of Pharmacovigilance; professionals should possess the appropriate knowledge and experience to establish and maintain an efficient Pharmacovigilance system.

Project Management is also vital to plan and coordinate various activities towards key deliverables, especially in drug development, which involves numerous stakeholders, or in cosmetic development where timelines for deliverables are more condensed.
Project Management aids in organising all project parameters and offers a clear perspective on the progress and visibility of potential risks. General introduction to Project Management, from inception to completion, will benefit a broad public audience.

Since training objectives vary based on the organisation, department and individual, a customised training for a specific organisation could be more productive and well received by employees as more pragmatic and relevant to their day to day activities. Before implementing this, it is advisable to conduct a comprehensive needs assessment to design the training package that aligns best with priorities and objectives. Aligning the training with business objectives, at the right time, will be a win-win situation in most cases.

General training could include for example (not an exhaustive list):

• Regulations in Drug Development from the early stage to Market Launch
• Specific regulations pertinent to specific regions of the world such as: European Union (EU), United States (US), Canada, Asian, Latin America, etc.
• Pharmacovigilance, PV system, QMS, SOPs, etc
• For Cosmetic Development:
  • Regulation in the EU (i.e. Regulation (EC) No 1223/2009), UK, US and Asia
  • Claims management
  • Labelling conditions
  • How to prepare a PIF
  • The Responsible Person
  • Cosmetovigilance