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Ilona Putz is the founder and General Manager of PULONA Emerging Markets based in the UAE since 2008. Her company is dedicated to creating and developing tailor-made business concepts including regulatory consultancy for international manufacturers in the healthcare sector across the Middle East. Ilona has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard, HEXAL and Sandoz where she was the Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities. She also consults for RegAff, Emergo and Dr. Regenold GmbH for the Middle East. Ilona spoke during the DIA Europe Meeting on “Clinical Trials in the Middle East” and at the Global Pharmaceutical Regulatory Affairs Summit 2021.

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.

Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at Maastricht School of Business. For the past 20 years Heba held the position of Middle East & Africa Regulatory and Quality Head at different Pharmaceutical and Medical Device companies; Gambro, Bayer and Novo Nordisk.

Heba is now the Middle East and Africa Associate Director at PPD where she is providing regulatory consulting services and training to Health Care companies.

Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialisation in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation. From 1975-1978 he was Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group). In 1978 he joined Ciba-Geigy in DRA. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs.

He has been consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organising Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia.

Since 1998 he has been an independent regulatory consultant and is Director of his own consultancy company Pharma International in Switzerland. He has also been director of two UK and Swiss registered pharmaceutical companies with specialised responsibility for international regulatory strategy. More recently as accredited by Swissmedic, Dr. Chalmers is a Qualified Person supporting several Swiss pharmaceutical companies trading internationally with pharmaceuticals and medical devices.

He is published, and his publications include a textbook on International Pharmaceutical Registration, Active Pharmaceutical Ingredients and as Swiss correspondent to the Regulatory Affairs Journals Pharma and Medtech. Since 2012 he has been a member of the Editorial Board, Scrip Regulatory Affairs.

Mustafa Edik is a leading pharmaceutical, biotechnoloy, medical device quality and GXP expert with over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.

As Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems (PQMS), he brings unmatched credibility and depth to audits, compliance strategies, and regulatory readiness. Holding a BSc in Chemistry, and a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA, Mustafa combines strong scientific foundations with strategic business acumen.

His career highlights include senior roles at Bayer Türkiye, where he progressed from Quality Control Lab Supervisor to Deputy QA Manager, and GMP Lead Auditor to Global GMP Lead Auditor, managing complex quality operations and audits in a multinational environment. He has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide.

Today, as Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, Mustafa delivers high-impact consulting, training, and project management services to local and global clients. His expertise spans across:

• GMP/GDP audits and supplier qualification
• Validation, qualification, and quality risk management (ICH Q9)
• Root cause analysis, CAPA, OOS/OOT, change control, and data integrity
• Sterile/non-sterile manufacturing, process improvement, and cost-of-quality optimisation
• Clinical trials (GCP & ICH E6), pharmacovigilance, and third-party manufacturing
• Regulatory alignment with FDA, EMA, PIC/S, MHRA, TGA, TMMDA, WHO, and ICH standards

Mustafa has trained over 9,000 professionals in GxP topics and designed certified auditor programs for Turkish authorities including Turkish MOH and Ministry of Agriculture and Foresty. He served as Principal GMP Consultant & Auditor at the Turkish Atomic Energy Authority, supporting successful TMMDA GMP approvals for 5 radiopharmaceutical products. As the first Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN), he has led teams of 100+ engineers, auditors, and quality specialists while managing dozens of international projects.

A prolific author, Mustafa's works include:

• “Sorularla GMP Dokümantasyonu” – a practical guide to GMP documentation
• “GMP Audits in Pharmaceutical and Biotechnology Industries” (Taylor & Francis / CRC Press, June 2024) – a comprehensive reference on effective GMP auditing practices

Recognised internationally for his practical, risk-based approach and knowledge transfer focus, Mustafa Edik is dedicated to elevating pharmaceutical quality standards, helping companies achieve compliance excellence, reduce risks, and drive operational efficiency.

Arun Singh (Prof) OBE, FRSA is an international lawyer and consultant to an international law firm. He was formerly a partner and head of commercial law at KPMG Legal and partner at Masons (now Pinsent Masons).

Arun has advised on disputes and collaborations in a wide range of jurisdictions including Europe, countries in West and East Africa, India, Bangladesh, China, Hong Kong, Saudi Arabia, UAE, Qatar, Pakistan, Libya, Jordan, Syria, the US, Caribbean, Russia, Israel, Lebanon, Egypt, Thailand and Singapore. Arun is cited and ranked in the Chambers Guide to the world’s leading lawyers. He concentrates on international investment, joint ventures, licensing of technology, research and development, M&A, energy, outsourcing and corporate governance in developed and emerging markets; he also handles international legal risk management matters. Arun advises a range of international organisations and is a visiting professor in International Business, Leadership and Negotiations at Salford University Business School, senior associate at Oxford University’s Institute of Legal Practice and teaches international leadership and negotiations at the University of Cambridge. He has facilitated programmes in Europe, Asia, the Middle East and the US.

He is a recognised corporate educator and a non-executive director of two international investment companies – one of which is listed on the London Stock Exchange, chairing the Audit Committee and Investment Committee.

He was appointed an OBE by HM the Queen in January 1999 for services to international trade, investment and intercultural management. Arun is an editor and contributor to a number of publications including Business and Contract Law (a Thorogood Special Report) and How to Lead Smart People – Leadership for Professionals (Profile Books) (recommended reading in the big four corporate advisory firms and basis for the popular international Coursera MOOC, University of London course 'Stepping Up: Leading Others').He is also a facilitator for company programmes and an experienced speaker at international corporate conferences.

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).

Nicole Reifman is a partner with McDonnell Boehnen Hulbert & Berghoff LLP, Chicago where she has gained diverse experience in obtaining, evaluating and enforcing intellectual property. She has experience in all phases of patent preparation and prosecution, and concentrates in representing clients in the mechanical and electrical arts, including drive train systems, medical devices, electromechanical, telecommunications and material sciences matters. She also has experience in all phases of patent litigation.

She provides counselling regarding the procurement, enforcement, and licensing of intellectual property rights, including trademark, trade secret and copyright issues. She actively manages trademark portfolios and develops brand building and protection strategies for her clients. She is also the Recent Developments Editor of the University of Illinois Journal of Law, Technology, and Policy.

James V. Suggs is a partner in the intellectual property law firm McDonnell Boehnen Hulbert & Berghoff LLP, located in Chicago, where he practices patent law and serves as Chair of the firm’s Chemical Practice Group. He applies his broad technical experience in a wide variety of chemical, polymer, materials science, pharmaceutical, optical, photonic, semiconductor and related technologies. He handles all facets of patent law, with an especial focus in patent procurement, strategic counseling, freedom-to-operate and due diligence opinions.

He also has an active inter partes review practice. His litigation experience includes federal district court and appellate practice as well as advocacy in forums such as the International Trade Commission, and spans a diverse range of technologies. He has experience with all kinds of clients, from large multinational corporations, to science-based startups, to academic research institutions, and works with law firms in Europe and worldwide to successfully prosecute their applications at the USPTO.

Linda Oyama is a microbiologist and lecturer at the School of Biological Sciences and Institute for Global Food Security, Queen’s University Belfast, with a first-class Microbiology degree and a PhD in Biological Sciences.

Linda’s research interests centre on understanding antimicrobial resistance (AMR) in microbiomes from a ‘One Health; perspective through surveillance and epidemiological studies using meta-omics approaches. She aims to tackle AMR through the discovery and development of novel treatment options for various clinical and veterinary multidrug resistant (MDR) infections.

Linda is a pioneer and executive group member of the UK Young Academy. She leads the AMR Hub at QUB and the Futures AMR Network (FAN), a UKRI funded ‘Transdisciplinary Network to Tackle Antimicrobial Resistance’ across human and livestock systems, whose vision is to harness young talent for innovation in tackling the AMR challenge with the support of world- leading AMR experts. She has an infectious, positive personality and a passion for the support and development of others, being always ready to help.