Regulatory Affairs Strategies
Expedite EU Drug Registration by integrating Regulatory Objectives
Course Objectives:
“Regulatory success is achieved by optimising early development strategies.”
More and more RA executives realise that the work done in RA departments is not enough, and that to capitalise on the product potential RA requirements have to be integrated from the early stages of the drug development.
This course has been designed to help you select the best registration strategy depending on the product area and indication. Submissions are delayed because of lack of CMC / non-clinical / clinical data, inaccurate indications being submitted, and inappropriate procedures being used. The financial consequences are potentially devastating.
This interactive 2-day course will provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.
What Will You Learn?
- Formulate regulatory strategies that achieve first class regulatory performance and compliance
- Speed up drug registration through skilled utilisation of registration procedures
- Reconcile R&D, clinical and marketing demands within the regulatory framework
- Manage the practical hurdles of submitting MAA/CTD within the deadlines
- Negotiate and respond to regulators’ questions successfully
- Understand the impact for your RA strategy of your product’s therapeutic area, proposed indications and other technical and development features
- Collect and present key information for the submission dossier to achieve a winning strategy
- Make the most out of the Centralised, Decentralised and MR procedure and get fast approval from regulators
Why should you attend?
- Achieve first-class regulatory performance and
compliance through strategic insight into drug
development and the registration processes - Take a product through all key development and
regulatory phases - Learn how to speed up drug-tomarket times
- Integrate CTD requirements from early stages of dossier
submission - Effectively manage the MRP and centralised procedures
- Improve your Regulatory Intelligence skills to ensure
competitive advantage
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Dates and Venues
29 Sep 2010 - 30 Sep 2010
Regus St James's Park, London, UK
Who Should Attend?
This course would be beneficial to people who have experience in RA and want to proactively take part in devising RA strategies, better understand the global picture of RA or become more familiar with the intricacies of product development and registration.
Some prior knowledge of the main regulations is assumed. It will also be relevant for experienced managers from other disciplines interacting with RA
• RASenior Executives
• Project Managers
• RAline managers
• RAteam leaders
• Clinical trials managers
• Clinical team leaders
• Regulatory Project Managers
• Managers from other disciplines representing
their departments on Project Teams including:
toxicology, pharmacokinetics, manufacturing,
pharmaceutical development and marketing.
Reviews
"Very nice overview of drug development from discovery to postapproval with good practical brainstorming exercises"
"Perfect!"
Related Events
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
