CPD Day Regulatory Update

Course Overview

On the 13 November, we will be running a CPD day to provide you with a broad overview of recent and proposed changes to the landscape of legislation and guidelines for control of manufacture of medicines in the EU. This will help you ensure that all requirements are implemented in a practical and effective manner.

The course is designed for: Qualified Persons/QP Sponsors, Quality Assurance Managers, Anyone responsible for Pharmaceutical Quality Management Systems and Regulatory professionals.

Legislation and Guidelines relevant to the manufacture of medicinal products in the European Union (EU) are constantly shifting. Since the beginning of 2016, legislation and/or guidelines on the following topics have either been implemented or published for future implementation:

• EudraLex Volume 4 GMP update to Annex 17, new Annex 21
• ICH Q12
• Medical Device Regulations
• Implications of Brexit on the UK Pharmaceutical Industry
• Annex 16 FAQ
• EMA guideline on quality of water for pharmaceutical use
• Mutual Recognition Agreement with America

In addition there are a number of topics in the pipeline:

• Clinical Trials Regulation
• Cleaning Validation by Toxicity Risk
• Assessment, updated MHRA Guidance
• Data Integrity