Upgrade your career with IPI - Training Courses for Industry Professionals

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Cheryl is currently the Global Head of Medical Writing at BioMarin Pharmaceutical Inc., and specialises in medical writing for serious and life‑threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and continued in positions in medical editing and medical writing in both the pharmaceutical and consultancy industry. She holds a degree in Medical Biology and a Masters in Neuroscience. Cheryl has been an approved workshop leader for the European Medical Writers Association since 2015 and gives training on subgroup analyses and orphan medicinal products. 

Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.

Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.

Shaun Stapleton is an independent consultant providing regulatory strategy advice and support to biopharma clients globally.

Shaun held positions of increasing responsibility in regulatory affairs at Sterling Winthrop, Eli Lilly, Boehringer Ingelheim and Ipsen, where he managed regulatory input into development programmes globally, securing new product approvals in the neurology, endocrinology and oncology therapeutic areas.

More recently, Shaun spent 8 years in regulatory consultancy at RRG (a Voisin Consulting Life Sciences Company) where he was a Director and Vice President of Regulatory Science working with global clients on a wide range of regulatory projects. From VCLS he moved to ReNeuron Ltd where he led regulatory, pharmacovigilance and latterly quality aspects of cell therapy and exosome development programmes.

Shaun has extensive experience in orphan drug development from first in man clinical trials through to commercialisation globally. He has been involved in discussions with regulators relating to specific orphan exclusivity issues and chaired the Alliance for Regenerative Medicine working group on “sameness” in the context of market exclusivity for orphan ATMPs (cell therapy). Most recently he was VP and Head of Global Regulatory Affairs at Amryt Pharma, a company specialising in the development and commercialisation of orphan medicines globally, where he contributed to the approval and life cycle management of several orphan drugs in areas of high unmet medical need.

Mark Weston has run his own law firm, Weston Legal, since 1 January 2024. He is also a consultant at Hill Dickinson LLP where he joined in February 2016 as a partner and Head of its Commercial, TMT & IP Practice. Before that, he was a partner and Head of the Commercial/IP/IT Team at Matthew Arnold & Baldwin LLP and before that, he spent several years at Baker & McKenzie in London and Chicago and has also previously been seconded to Hewlett Packard and other technology businesses. He changed role to become a consultant in Hill Dickinson’s London office in January 2024.

Expertise: Mark’s practice covers both non-contentious and contentious matters in all areas of commercial law, intellectual property law, information technology law, Internet, electronic commerce and on-line services law. He specialises in commercial and Tech issues. Mark is used as a ‘trusted adviser’ by many clients in all sorts of businesses and often acts as ‘private practice in-house counsel’ for many clients. He specialises in tech and internet businesses.

Clients: Just some of Mark’s more well-known clients include Elstree Film Studios, RTL Group S.A., Sykes Cottages, Retailcorp Brands LLC, The Gulf Marketing Group, Moneynetint Limited and the BBC.

Some detail: Mark has extensive experience in advising clients on all manner of commercial matters (such as business planning and solutions, franchising, distribution, agency and marketing) through branding and intellectual property exploitation and licensing, to advice and documentation regarding hardware and software issues (such as development, licensing, maintenance and distribution, SaaS and cloud, Internet transactional solutioning, B2B, B2C and B2G electronic commerce, S-commerce and M-Commerce, social media, outsourcing, facilities management, procurement, IT policies, data protection (privacy), GDPR and freedom of information issues as well as artificial intelligence (AI)). He has a particular expertise in new digital business and revenue streams. He is also experienced in dealing with software disputes and IT litigation. The increasingly extensive media side of his practice relates primarily to publishing (both real world and digital content), to games and gaming platforms (and particularly transmedia technologies), advising companies about their advertising onscreen, online and in print and managing their public communications strategies generally (dealing with the CMA and ASA in the process) – and also a smattering of television, film and music exploitation. Recently he has been very active in AI advice.

More unusual: 

Mark has previously spent several months on secondment to Hewlett Packard and he has also been seconded to assist in the legal problems arising in new technology companies such as Symbian. From 2000 to 2001, Mark was resident in the Chicago office of Baker & McKenzie advising US clients on European and UK aspects of IT and electronic commerce law and practice.

Mark is the author of the Legal Practice Companion, a parallel text book used at several law schools, the editor of the IP and Media Law Companion as well as the rest of the Companion series of books published by Bloomsbury Professional, Tottels, Cavendish Publishing and Oxford University Press. He has noted numerous reports for the IT Law Reports and is widely published in Computing, Computers & Law, Computer Law & Security Report, IT Law Today, Intellectual Property World, Solicitors Journal and many other journals both online and offline. Mark has also authored articles syndicated in the national and trade press and is regularly quoted in national newspapers and is heard on radio as an expert in his fields. Mark is the author of the Business Names on the Internet chapter in the PLC Ecommerce Manual as well as numerous other articles on various Commercial & IT law topics.

Mark lectures regularly on all Commercial, IP and IT law topics, including at the IBC IT ‘Summer School’ Programme in Cambridge, England; the Falconbury and MBL two-day and three-day Commercial Contracts seminars (run several times a year) and IT Contracts seminars (run three times a year) in London; and he has previously lectured at the Annual On-line & Internet Commerce Law Institute seminar in Chicago and tutored at University College London.  He also runs a programme of bespoke training schemes on commercial law, IP law, IT law, AI law and data law as well as soft skills programmes such as negotiation skills and presentation skills.

Finally, you may have seen that Mark likes blogging and writing books, which are available at all good bookshops! He also appears regularly on BBC1 (usually providing advice on-screen to BBC Watchdog) and also on Sky News as a legal commentator, as well as trying to avoid the huge quantity of pink powder the TV make-up girls want to apply to his increasingly receding hairline.

JoAnna Emery, CLAS, F.Inst.Pa, is Project Manager, Intellectual Property at atai Life Sciences.
Previously, JoAnna was Senior Intellectual Property Paralegal for Cambridge Mechatronics Limited
where she was responsible for aiding in the management and growth of the patent portfolio.
Prior to that she was the Head of and Director for Pure Ideas Limited where she managed the
strategy, P&L, KPIs and intellectual property operations of the firm.

JoAnna has over 27 years experience in intellectual property in both the US and England. She holds an Associate and Bachelor’s degree in Paralegal Studies from Rivier College.

Geoff Marsh is the Managing Director of Dansam Ltd, a training company that began in September 1999. 

Geoff started his career as a presenter in 1986 on the Lloyds Bank's 'Customer First' Programme. This was one of the largest series of roadshow workshops in the world at that time. The programme was seen by approximately 70,000 staff.

Geoff has presented courses with Management Forum for nearly 20 years.

In addition he has delivered training and coaching programmes for Robert Bosch Ltd, London Underground, Scottish and Newcastle Breweries, Rohm and Haas, Serono Pharmaceuticals, Domino Printing UK Ltd, Kall Kwik Printing, The Engineering and Physical Sciences Research Councils, Linton Lubricants, Halliburton, Interserve Project Services, The Midlands Co-op Funeral Division and many others.

Geoff has particular expertise in the financial services sector and his clients include organisations such as Coutts, Acin, Barclays Wealth, Lombard Odier, Lloyds Bank IPB,  JP Morgan, Citibank, Bank Of Vietnam, Bank Of Singapore, Siam Commerce Bank, Bank of Georgia, Caledonia Investments,  Unigestion,  Taib Securities, , Asquith, Cheviot Asset Management, Ernst & Young, Nationwide, Fleming Family and Partners and Rothschilds.   His work for these organisations has ranged from management and leadership skills, teambuilding, communication, presentation skills, front line sales and negotiation training as well as dealing with demanding clients, cold calling and asking for referrals. 

As a trainer and presenter, Geoff has been involved with conferences, seminars and roadshows for organisations such as Kall Kwik, The Color Company, Alphagraphics,  Regus, Great Western Railways, Wessex Water, Vision Box, Viapath and The Zoological Society of London.

Geoff is an international trainer and presenter and has worked outside the UK for organisations such as United Airlines, American airlines, Qatar Airways, BNP Paribas, HSBC, OCBC, Maybank and Unichem

He has been a visiting lecturer on the Swiss Finance Institute executive IWEMBA (International Wealth Management Executive MBA) programme. He has been a guest lecturer with the IE Business school in Madrid and has worked with the Singapore Wealth Management Institute (WMI) and the Singapore Management University for more than 14 years on their Masters in Finance programme (in conjunction with the Singapore Management University and the Nanyang University of Technology.

In addition Geoff is also much sought after as a presenter and after-dinner speaker. He has had his own weekly radio shows on Swindon FM and Swindon 105.5. He is the author and co-author of several books including 'High Performance Presentation Skills', ‘A Sixty minute Guide To Powerful Presentations’, ‘A Sixty minute Guide to Developing Key Accounts’ ‘A Sixty Minute Guide To Franchising’, and ‘A Sixty Minute Guide To Direct Mail’. 

A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).

Jason Brown brings a wealth of knowledge and practical experience to his role as Senior Analytical Sciences Manager at Adare Pharma Solutions, where he serves as the global nitrosamine subject matter expert. He has led Adare’s innovative approaches to understanding nitrosamine formation, measurement, and mitigation to ensure regulatory compliance internally and for our customers. Jason has led numerous dialogues on the subject of nitrosamines through panel discussions, webinars, posters, articles, and regular contributions to the USP Nitrosamine Forum. Jason has a BS in Chemistry from George Fox University.