Applied Regulatory Consulting

We provide a broad range of learning and training in the area of regulatory affairs tailored to the individual needs of the clients. This can be delivered in a variety of ways to suit the requirements of the delegates.

What subjects can we help you to better understand?

We have a depth and breadth of knowledge that equips us to deliver training in most subject areas relevant to regulatory and other professionals, especially those in the pharmaceutical industry. Below are some examples of training we are able to offer our clients.

• Regulatory Intelligence: This includes why regulatory intelligence has become an essential requirement for any pharmaceutical company, as well as the key concepts that are important to understand effective regulatory intelligence. We can also provide important insights in how to undertake successful research to establish regulatory precedents, and the processes and methods essential for keeping up to date and disseminating relevant information in the fast-changing regulatory landscape.
• e-submissions: Today most countries expect or accept various regulatory submissions electronically, whether this is the eCTD, NeeS or other formats. We provide information about the latest requirements and tips for how best to deliver robust e-submissions to the regulatory agencies.
• Introduction to European regulatory affairs: The European Union is made up of 27 different countries. Some aspects of the regulation of medicines are at a pan-European level, yet national sovereignties mean that the majority of the regulation is still at a national level. This, together with the on-going increase in member countries, means that the regulatory landscape in Europe is extremely complex. We can enable you to understand how this all fits together and how to find information relevant to your needs. We can also help you be aware of the harmonisations, co-operations and differences that exist among the regulatory agencies and authorities in Europe and across the regions of the world.

These serve as just examples of what we can help you to learn about regulatory affairs and operations.

How can we deliver your training?

We can deliver your training using a range of different methods. Below are some examples of how we can achieve that.

• Face-to-face: Our experts can provide training workshops or lectures in person. These can be arranged either at your company premises or at an alternative venue as appropriate.
• Distance learning: We provide a variety of options for providing distance learning. For example, we can deliver workshops and lectures using web-conferencing solutions. We can also supply training using a paced tutorial approach, utilising web and e-mail platforms.

If you would like further information or to discuss how we can help you with your training, please contact us.