Being a regulatory affairs professional in a pharmaceutical or biotech company is both challenging and rewarding. As a senior professional you must ensure compliance for all new and existing products at the same time as managing budgets and keeping to business critical deadlines. Regulatory affairs leaders must think strategically, aligning their regulatory knowledge to the wider organisational goals and objectives.
This 3-day course will examine the current European legislation and help you to understand the consequences for Regulatory Affairs Managers. You will take a strategic approach to regulatory affairs on a variety of topics such as clinical regulations, pharmacovigilance, submissions, labelling, manufacturing and lifecycle management. Crucially you will assess the role of management as a regulatory professional. You will also compare the regulatory requirements in Europe with the rest of the world.
Once completed delegates will be fully up-to-date with the latest legislation and be equipped with the knowledge and confidence to instigate the optimisation of in-house regulatory procedures.
There will also be additional time for delegates to discuss the implications of Brexit on this subject matter.
Regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.
Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.
Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.
Anyone working within the field of regulatory affairs at management level or above, such as:
We're looking forward to welcoming our attendees and expert course leaders at Advanced European Regulatory Affairs in London in April.
Our number one priority is the safety of our delegates and colleagues, and there are always measures in place at our venues to safeguard your health and safety. There are extra measures in place for 2020 in light of developments with COVID-19.
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