Meetings

Speakers:

Neil Raw, GMP Inspector - MHRA and Martyn Becker, MD - Martyn Becker Associates (and ex MHRA) already confirmed

Summary:

If you were to ask an analyst, section head or indeed a manager to describe the regulatory process from discovery to release to the market, how many would provide the correct answer? In Pharmig's experience, microbiological regulatory issues are always discussed but not many of us actually understand the regulatory process itself and where microbiology fits into the process.

This meeting is aimed at microbiological managers, section heads, middle managers and QA staff new to the pharmaceutical industry. The meeting will provide an overview of the structure and function of the regulatory bodies and how they interact with each other and the pharmaceutical industry. A presentation will describe the regulatory process from product discovery to product release and where and why microbiology is important on the product life cycle. As always current regulatory hot topics are a good source of information for you and your organisation's quality system, furthermore you will hear direct from the MHRA as to what they are reviewing. The meeting will allow attendees to keep abreast of the key regulatory issues and guidance documents and how they impact on microbiology.

Overall this meeting will provide you with a sound understanding of the regulatory set up which can be passed onto your peers/staff in your organisation.

Programme includes:

• Review of current Regulatory hot topics.
• Regulation of the Pharmaceutical Industry - Historical overview.
• Regulatory Body - structures & organisations.
• What are the Regulations and what are the Guidelines pertinent to the micro arena?
• Designing a Regulatory road map.
• Pharmacopoeial changes and their impact on the micro arena.