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TMCNet:  Research and Markets: Regulatory Affairs for Support Staff - An Overview of the Pharmaceutical Regulatory Affairs for Support Staff (Course, London)

[January 24, 2014]

Research and Markets: Regulatory Affairs for Support Staff - An Overview of the Pharmaceutical Regulatory Affairs for Support Staff (Course, London)

DUBLIN --(Business Wire)--

Research and Markets (http://www.researchandmarkets.com/research/vqfzwn/regulatory) has announced the addition of the "Regulatory Affairs for Support Staff - An Overview of the Pharmaceutical Regulatory Affairs for Support Staff (Course, London)" conference to their offering.

The Regulatory Affairs for Support Staff course will be held on the 20th & 21st March 2014 at the Rembrandt Hotel, London

Topics to be covered:

- Learn about the Drug Development Process - from Drug Discovery to Product Launch and Beyond

- Understand the Background of European Law - Regulations, Directives, etc.

- Discover where you can find Information on Regulatory Affairs, Approvals, Withdrawals, etc.

- What is the Centralised Procedure

- How to Seek Scientific Advice in Europe

- What is the Common Technical Document

- Applying for a Marketing Authorisation in the EU

- Key Aspects of Drug Safety Reporting

- Pharmacovigilance and GCP Inspections

- Managing Product Labelling

- Discussion on Licence Variations

- Understand Parallel Imports and Generic Applications

This two day course provides an introdction to Regulatory Affairs and the basics of drug development and has been designed specifically for those working in a support staff role.


The first day will provide an overview of the EU Regulatory procedures, an insight into applying for clinical trials applications and seeking scientific advice and how to maintain product labelling whilst complying with pharmacovigilance requirements. You will gain an overview of the basics of the registration procedures and how to organise the registration files.

The second day will focus on the procedures required to register products in Europe and the Regulatory activities that need to be complied with to keep products on the markets. Pharmacovigilance and safety reporting will be covered as well as licence variations and the commercial aspects of pharmaceutical products.

The course will provide a thorough grounding in the subject of Regulatory Affairs and will enable you to perform in your role more effectively.

WHO SHOULD ATTEND

This course is specifically designed for anyone who is new to Regulatory Affairs, including personal assistants, secretaries, administrators and any member of support staff wishing to gain a greater understanding of Regulatory Affairs in the Pharmaceutical Industry. It is also suitable for those who interface with the Regulatory Affairs function and who provide support to the Regulatory procedures and activities.

DOCUMENTATION

Participants will receive a course material folder containing comprehensive documentation provided by the seminar leader, which will be a valuable source of reference for the future.

A Certificate of Attendance for Professional Development will be given to each participant who completes the course

DATES:

20 & 21 March 2014

TIMES:

20 March 2014 Start: 09.30 - Finish: 17.00

21 March 2014 Start: 09.30 - Finish: 17.00

REGISTRATION & COFFEE

20 March 2014 09.00

VENUE & ACCOMMODATION

The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS

DIRECTIONS:

Opposite V&A Museum. Nearest underground station: South Kensington.

For more information visit http://www.researchandmarkets.com/research/vqfzwn/regulatory

About Research and Markets

Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.


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