GMP for Investigational Medicinal Products
Date : 21 February 2019
Time : 11 : 00 AM EST
Duration : 60 Minutes
MADELEINE S. FAIRWEATHER Ph.D., MRSB, is a freelance GMP course writer and presenter. Her background is quality assurance of biological and botanical APIs. She has specialist knowledge of therapeutic antibodies, blood, and plasma, as well as recombinant DNA vaccines, siRNAs and materials requiring special handling. She has been involved in technology transfer and ongoing auditing of API suppliers for nearly twenty years which has taken her throughout Europe, to the USA, Australasia, and Asia. She has successfully ensured the manufacturing quality of active substances as well as final products and investigational medicinal products (IMPs/INDs) and has guided sponsors and suppliers in achieving licenses for global markets. Madeleine also provides specialist advice and expertise on importation testing and supplier audits.
EU good manufacturing practice with regard to medicinal products for human use and investigational medicinal products for human use, as per EU Commission Directive 2003/94/EC; the Falsified Medicines Directive 2011/62/EU, the Human Medicines Regulations 2012, and Commission Delegated Regulation (EU) 2017/1569, specifying the principles of and guidelines for good manufacturing practice for investigational products for human use and arrangements for inspections. GMP for Advanced Therapy Medicinal Products (Part IV, Eudralex Vol. 4) as of May 2018 and the latest on materials manufactured under a Specials license. US FDA Investigational New Drug requirements.
- An update of the rules and requirements within the European Union and EEA
- Distribution of IMPs: Import from Third Countries into EU Member states for use in Clinical Trials
- QP authorization
- Brexit impact
- Clinical trial design and the GMP/GCP interface
- Manufacture of IMPs under license
- The quality management system
- Role and responsibilities of QA and the QP
- APIs and excipients
- QC testing
- Packaging, labeling and trial randomization
- GDP in terms of supply, return, reconciliation and destruction of unused IMPs
- Complaints, recall of product and emergency unblinding
Course Level - Medium to advanced
Who Should Attend
Regulatory, quality assurance, quality control personnel, managers, study directors, principal investigators and personnel associated with labeling, storage, release, distribution, and reconciliation of clinical trial stock.
Why Should Attend
Latest update regarding common GMP inspection issues with IMP manufacture; the responsibilities assigned via technical agreement, QP duties, the importance of back-auditing. Change management, recording, and investigation of quality defects, control of label printing, supplier approval, and manufacture versus reconstitution. A non-licensed product, specials and rescue medicines. Import and export considerations.
- Speaker: MADELEINE S. FAIRWEATHER
- Webinar Code: MADE-0001