The ICH Common Technical Document (CTD) has brought the possibility of a global dossier many steps closer.

Regulatory Resources Group (RRG) and David Begg Associates (DBA) have combined their complementary skills to present this course which is designed to provide attendees with a clear understanding of the European regulatory process and technical data requirements with a special focus on differences compared to the US approach. 

The course is based on a similar one run annually by RRG and DBA in Europe, currently in its 20th successful year. RRG and DBA have a proven track record of running successful and highly regarded residential and in-house training courses in Europe and the US, covering a wide range of regulatory and quality issues for professionals working within the pharmaceutical industry.  By attending this course you will obtain detailed insight into the EU regulatory system and CMC requirements from experts with extensive and current hands-on experience working with industry and regulatory agencies across Europe.

Who Should Attend?

This course will be invaluable to professionals who already have an understanding of the requirements for drug product registration in the USA and who wish to gain an understanding of the processes and procedures applicable in the European Union. These professionals are likely to come from the following areas:

• Regulatory Affairs
• CMC Regulatory Affairs
• Quality Assurance and Compliance
• Project Management
• Research and Development
• Manufacturing
• Document management

Location: Royal Sonesta Hotel, Boston, MA

Date: March 16 - 18, 2010

Details: www.DBA-global.com

Course Outline

• Legal framework for drugs in the EU and EEA
• The role of the EU Qualified Person (QP)
• Batch Release and responsibilities in the importation of Drug Product
• GMP declarations
• Interface with Regulatory Affairs
• CTD submission structure and content for new and existing products
• Data requirements for new and established products focusing on EU specific aspects
• Drug substance information, including drug master files and certificates of suitability
• Pharmaceutical development and the impact of ICH Q8
• Manufacturing process and validation/Process Analytical Technology (PAT)
• Control of Excipients
• Specifications
• Container Closure
• CTD summary documents
• The role of the EU expert
• EU Marketing Authorisation procedures (Centralised, Decentralised and Mutual Recognition)
• Manufacturing Authorisations -for commercial and clinical trial products
• Clinical Trial Applications
• GMP inspections
• Post approval changes - variations
• Risk Assessment in Regulatory Affairs

Your Instructors

Peter Smith

David Begg Associates, UK

Peter Smith has extensive and varied pharmaceutical manufacturing and QA experience spanning 12 years, firstly in production supervision and moving on to senior management positions in sterile production and general manufacturing management. Peter has 6 years experience with the UK Medicines Inspectorate as specialist Principal Inspector with responsibility for non-sterile processing and packaging of pharmaceuticals. Peter is an experienced educator and brings a wealth of experience and knowledge of international GMPs to each session he teaches.

Shaun Stapleton

Regulatory Resources Group, UK

Shaun Stapleton has 20 years' experience of global regulatory affairs with particular expertise in European regulatory systems. In his role as a consultant with RRG Shaun has provided regulatory advice to companies on a wide-range of products from OTC medicines through to advanced therapies. He also has extensive experience with peptides, modified release injectable formulations and orphan drugs. Shaun is a former member of the EFPIA Regulatory Affairs Ad Hoc group and became a Director of RRG in January 2008.

To Register

You may register online at www.DBA-global.com by clicking on US Residential Courses. Payment is accepted by credit card.

Complete the enclosed booking form if you wish to pay by check or by invoice. DBA offers a discount of 20% for bookings received eight weeks in advance of the course start date.  In addition, the second person booking from the same site is entitled to a 20% discount (discounts are not cumulative).

Course Fee: First/only delegate attending -$2675. Additional delegate(s) from same site -$2140 (or 8 week early payment discount).