London, United Kingdom, February 01, 2019 --(PR.com)-- Amongst the myriad of potential pitfalls for the Highly Potential Active Pharmaceutical Ingredients (HPAPI) industry there is a requirement for all parties involved to have a blueprint in place to ensure all containment procedures are followed correctly. Yet, there is also a need to ensure that operations are maintained at the highest standards. At SMi�s 3rd Annual Highly Potent Active Pharmaceutical Ingredients Conference these issues will be discussed along with design and build of a new compound, risk assessment of HPAPI products and utilisation of control matrices.

Key Sessions include:

Panel Discussion:

Control matrices, control algorithms, containment guides and confidence
- Importance of control matrices and algorithms
- Current status of containment guides
- Methods of optimising confidence towards worker safety
- Future of containment designs

Mr Peter Marshall, Associate Engineering Director, AstraZeneca
Mr Nigel Saunders, Technical Engineer - SME Containment, GSK
Dr Thomas Adam, Head of Global Quality Assurance Chemical APIs, Bayer

Internal procedure guide in handling high potent compounds
- Bayer quality organisation guidelines
- Internal procedures to minimise the risk of handling HPAPIs to workers
- Deciding the correct control based on a correctly identified hazard

Dr Thomas Adam, Head of Global Quality Assurance Chemical APIs, Bayer

Development and manufacture of HPAPI products through the clinical phases from molecule to market

- How HPAPIs can be developed into suitable drug dosage forms
- Strategies to adhere to the highest quality standards
- Complexities at each stage of the development cycle from FiM studies to global supply

Mr David O�Connell, Director Scientific Affairs, PCI Pharma Services

Deep Dive � Case Study

Risk assessment of highly potent APIs cross-contamination and transportation parameters
- Guidelines regarding quality risk management
- Case study 1: technical aspects and complexity in cross contamination risk analysis
- Case study 2: temperature deviation during transportation

Dr Ildik� Ziegler, Distinguished Validation Expert, Gedeon Richter

Design and innovation of a new compound facility
- Reconstruction guidelines for adapting existing facilities to meet the needs of HPAPIs
- Ensuring facility reconstruction meets GMPs
- Additional assets required for HPAPI adaptation
- Designing controls and training to address worker safety

Dr Jack Brown, Senior Principal Scientist, Boehringer Ingelheim

View the programme at www.highlypotentapi.com
Registrations made before or on January 31st will include a �400 discount of the standard price.

Conference: 13th and 14th May 2019
Post-conference workshop: 15th May 2019
Holiday Inn Kensington Forum, London, UK