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SMi is delighted to announce its 4th Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 11th-12th May 2020.

The increasing demand for medicines that target diseases more effectively and with fewer side effects is leading HPAPI market expansion with a CAGR of 10.3%. It is forecasted that by 2024, the HPAPI oncology market will be worth close to $100 billion.

As such, these highly potent substances predispose workers to higher risks of exposure and consequently, need to be manufactured according to strict criteria. Limiting exposure has become one of the biggest hurdles of the HPAPI industry resulting in an increasing need for containment solutions aimed to reduce the risk of hazard and to prevent cross-contamination. With elevated risk come stricter regulatory guidelines that pharmaceutical companies and contract manufacturers need to adhere to.

The 4th year of this conference series focuses on the growing HPAPI landscape driven by the demand for highly potent drugs in oncology, diabetes and autoimmune disease treatment. This event will address the biggest challenges the industry is facing with regards to determining toxicology limits, assessing hazards, implementing risk procures, translating risk assessment into facility engineering, preventing and dealing with cross-contamination and adhering to GMP regulatory guidelines.

Attend this conference and join our networking platform for industry professionals to provide you with the expertise to overcome the challenges of the HPAPI industry.

  • Explore HPAPI manufacturing with 8 big pharma from both the toxic substance and the employees’ perspective
  • Gain better understanding of human factors and ergonomics aspects and their role in improving production performance – NEW FOR 2020!
  • Deep dive into the oncology market and ADC production, the main driver of the HPAPI industry- NEW FOR 2020!
  • Learn what it takes to create a safety company culture and how to better train your employees on risk perception
     

Directors, Heads, Managers, Principal Scientists of :

  • Occupational Toxicology
  • Industrial Hygiene
  • EHS/ SHE
  • Validation
  • Risk Assessment
  • Containment Engineering
  • Manufacturing/ Production
  • Process Development
  • Supply Chain/ Operations
  • Product Quality
  • Formulation Development
  • Regulatory

3i France; 3P Innovation Ltd; AbbVie; Accord UK; ADC Biotechnology Ltd; Antikor Biopharma Ltd; Ascendis Pharmaceuticals; AstraZeneca; Bayer AG; Bayer Pharma; Boehringer Ingelheim Pharmaceuticals, Inc.; BSP Pharmaceuticals S.p.A.; Catalent Pharma Solutions Inc; Dec Group; DSTL; Egis Pharmaceuticals PLC; Ferring Pharmaceuticals A/S; Gedeon Richter Plc.; GSK; GVK Biosciences; HPAPI Project Services Limited; Ipsen Bionnovation Ltd; Laurus Synthesis; MedinCell; Minakem; NNE AG; Novartis Ag; Novo Nordisk; Novo Nordisk A / S; NPI & Product Technology; Oril Industrie; PCI Pharma Services; Pharmadagio Limited; Regeneron Inc; SafeBridge Consultants, Inc; SafeBridge Europe Ltd; SK Biotek; Solo Containment; Speciality Chemicals ; Takeda Pharmaceuticals;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

9:10 Characterizing Highly Potent APIs – Introduction to Occupational Toxicology

Martin Kohan

Martin Kohan, Senior Occupational Toxicologist, AstraZeneca
View Bio

• Toxicology – What makes a compound highly potent?
• Occupational Toxicology and Exposure Limits (OELs & PDEs) and Bands (OEBs)
• How are Exposure Limits and Bands established?
• Why we need Exposure Limits and Bands?

9:50 Occupational Banding Systems

William Hawkins

William Hawkins, Manager Occupational Toxicology, GSK
View Bio

• A brief history of occupational exposure banding.
• The use of Occupational Banding systems
• Toxicology of new compounds with novel mechanism of action – a case study

10:30 Morning Coffee

11:00 Technical elements of a successful cross contamination risk assessment

Ildiko Ziegler

Ildiko Ziegler, QA Manager, Gedeon Richter Ltd
View Bio

• Guidelines regarding Pharmaceutical Quality Risk Management
• Technical aspects and complexity in cross contamination risk analysis
• Case studies

11:40 Respirators and their effectiveness in reducing particulate exposures

John Cherrie

John Cherrie, Professor of Human Health, Heriot-Watt University

• Respirators are widely used to protect workers from inhaling airborne dusts, including APIs
• It is often said that respirators are ineffective, but if used properly they can offer a high degree of protection
• Selection of the right equipment and training of the workers to wear it correctly will ensure the best outcome
• Respirators should be used in conjunction with engineering measures in a comprehensive exposure control programme

12:20 Networking Lunch

13:20 Performance Beyond ‘The Number’ – Exploring the Reliability of Containment Performance Data

Mike Perry

Mike Perry, Director, Pharmadagio Limited
View Bio

• The role, scope and limitations of containment performance testing explained
• Interpreting the ISPE Guide – how choice of sampling strategy, data interpretation, human factors and statistics will influence test outcomes
• Purchasing containment equipment and communication – examples of marketing language and finding the right questions to ask.
• Pushing the boundaries – the role of containment performance testing in HPAPI settings

14:00 Manufacture of highly active drug products in shared facilities

Andreas Schreiner

Andreas Schreiner, Head Validation Manufacturing Science & Technology, Novartis
View Bio

• Expectations from health authorities
• Cross-Contamination mitigation strategies
• Case Studies

14:40 Afternoon Tea

15:10 How to handle HPAPIs in the Small Scale HPAI Facility

Thomas Adam

Thomas Adam, Head of Global Quality Assurance Chemical APIs, Bayer AG
View Bio

• GMP-Compliance and Regulatory Environment
• Cleaning of Equipment in the Manufacturing of HPAIs
• Prevention of Cross-Contamination in Shared Facilities
• Case study

15:50 Chair's Closing Remarks

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

16:00 Close of Day One

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

9:10 Overview of ADC manufacturing

Francois D Hooge

Francois D Hooge, ADC Project Manager, Gamamabs Pharma
View Bio

• Overview of ADC mode of action and global pipeline
• ADC production steps
• Examples with PBD payload synthesis and conjugation

9:50 CMC Strategies For The Timely Launch Preparation of Antibody-Drug-Conjugates as High Potent APIs

Ulrich Rumenapp

Ulrich Rumenapp, Head of Launch Preparation and Coordination, Bayer AG
View Bio

• The manufacture of highly potent ADCs - challenges and solutions
• Deciding when to outsource and when to keep in-house
• Bayer’s ADC production concept
• Best practices for CMO selection and outsourcing ADC development and manufacture
• The journey from development to launch - understanding the needs, solutions, risks and mitigations

10:30 Morning Coffee

11:00 Engineering in support of ADC containment – a case study

Peter Marshall

Peter Marshall, Associate Engineering Director, AstraZeneca
View Bio

• Innovative solutions to dealing with increasing toxicity of ADCs
• Designing ADC containment systems
• The containment of ADCs – a case study from AZ

11:40 Putting the human at the centre of system design in HPAPI manufacturing

Brian Edwards

Brian Edwards, Chair, CIEHF
View Bio

• Understanding the role human factors play in pharmaceutical manufacturing and how a novel UK group
Is helping to drive change
• Outlining key principles how the tools and technologies, workplace or system can be designed and adapted to suit the people who need to use it
• How human factors underpin all quality management systems

12:20 Networking Lunch

13:20 HPAPI manufacturing; an outlook on Health

Martin Hogan

Martin Hogan, Managing Director , Corporate Health Ireland
View Bio

• Reproductive issues in both males and females
• How to deal with pregnant employee
• Concerns regarding potency of product etc (carcinogens, mutagens etc.)

14:00 Developing Effective Guidelines and Training to prevent Potential Exposure to High Potent Compounds

Michoux Pascal

Michoux Pascal, Vice President, Global EHS Teva api & Biologics, Teva Api Div
View Bio

• Setting the expectations and the provision of clear guidelines, standards and risk management tools
• Developing employee awareness, technical capabilities and core competencies.
• Measuring training and programme effectiveness for continuous improvement

14:40 Afternoon Tea

15:10 How to train your employees right on lab safety?

15:50 Chair's Closing Remarks

Justin Mason-Home

Justin Mason-Home, Director, HPAPI Project Services Limited
View Bio

16:00 Close of Day Two

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Official Media Partner

Key Media Partners

Supporting Media Partners

Workshops

Practical Steps for Delivering HPAPI Projects
Workshop

Practical Steps for Delivering HPAPI Projects

Copthorne Tara Hotel
13th May 2020
London, United Kingdom

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

HPAPI 2020 Brochure

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Highly Potent Active Pharmaceutical Ingredients Programme

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Highly Potent Active Pharmaceutical Ingredients Attendees 2019

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Media Partners


Speciality Chemicals Online

Official Media Partner
https://www.specchemonline.com/

Published continuously since 1981, Speciality Chemicals Magazine is the leading monthly magazine dedicated to covering business, markets and technology in the fine and speciality chemicals industries world-wide. We have over 50,000 readers and a calendar of features covering the full gamut of applications, including pharmaceuticals, agrochemicals, cosmetics and personal care, biobased chemicals, surfactants, biocides and much more.

Media Partners


pharmaphorum

Key Media Partners
http://www.pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com

Media Partners


Gate2Biotech

Supporting Media Partners
http://www.gate2biotech.com

Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


ASD MEDIA

Supporting Media Partners
http://www.asd-network.com

Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
  • Be informed on the latest market developments; www.asd-network.com
  • Find the latest business news; www.asd-network.com
  • Find the upcoming events; www.asd-network.com
  • Find companies and organizations; www.asdsource.com
  • Distribute news globally. www.asdwire.com
The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

For more detailed information please contact with: ASD MEDIA
Stefan.koopman@asdmedia.nl


Mednous

Supporting Media Partners
http://www.MedNous.com

MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


International Pharmaceutical Industry

Supporting Media Partners
http://www.ipimediaworld.com

IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


Pharmalicensing

Supporting Media Partners
http://www.pharmalicensing.com

Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.

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Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

Copthorne Tara Hotel

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

HOTEL BOOKING FORM

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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