Speakers

Peter Brown has been a Medicines Inspector since October 2015, and was appointed to the post of Senior Inspector in March 2019, following a long career in wholesale operations and quality management. His current portfolio encompasses leading inspections around intelligence led or suspected serious non-compliance management. This role includes supporting criminal investigations, and he has recently utilised this experience to update MHRA guidance around high risk areas of compliance, including bona fide qualification.

Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020.
Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG).

Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

Thomas De Bie was appointed CEO of CAPPI on 1 February 2016. His early career was spent in sales and marketing and spearheaded CAPPI’s European expansion. He holds a Master of Science in International Business. Dutch from origin, Thomas lives and works in France since 2006.

"Andreas Krassnigg is head of GMDP inspection's Departement at the Austrian Federal Office for Safety in Health Care since 2006.
He is responsible for Manufacturer's and Wholesaler's Authorisations and related inspections and certificates. In his position he is Austria's delegate to the Inspector's Working Group at the European Medicines Agency and Austria's Committee Member of Officials at the Pharmaceutical Inspections Cooperation Scheme, where he is currently also Chair of the Subcommittee on Expert Circles.
After studying pharmacy at the University of Innsbruck, Tyrol, Andreas Krassnigg worked several years as a pharmacist. His core experience is in the field of herbal medicines, traditional pharmaceutical manufacturing, Good Distribution Practice and transportation."

Ethel Mertens obtained a degree in Pharmacy at the University of Gent and started her career by working in a pharmacy. After a few years, she began working for the department of ‘Hormones and Antibiotics’ and ‘Borderline Products’ in the Belgian Federal Agency for Medicines and Health Products. In 2007, she changed her orientation to become a GMDP inspector, specialised in GDP. Since 2008, she has been a member of the GDP drafting Group at the EMA. In September 2014, she became Head of the Distribution of the DG Inspection Division (also at the FAMHP).
In September 2015, she was appointed as the Director General ad interim of the Directorate General Inspection and since February 2018 as Director General.

Ms Nolan is a chemist having completed her Ph.D. and post-doctoral research at Trinity College Dublin in transdermal drug delivery. She worked for a number of years in private industry in the area of enhancing and developing drug delivery systems, and also within the state forensic science services.

Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency.

Martin was a government official for 7 years, including nearly 3 years in the office of the UK Prime Minister.
At HDA, Martin is responsible for the mission and all operations of the Association, which has included a Government minister’s launch of the HDA ‘Gold Standard of Good Distribution Practice’ in the UK Parliament, and the constant engagement of stakeholders, regulators and policymakers on many NHS and healthcare issues. In 2016, the launch of the re-named Healthcare Distribution Association emphasised the Association’s desire to embrace medicines supply developments and restate the value of the sector. In 2020, through the HDA, the UK’s medicines distribution sector has been able to more publicly demonstrate its value to the UK’s healthcare system in the fight against Covid, which has been recognised by the UK Government. Martin also represents the sector on the board of SecurMed UK, the UK’s national medicines verification organisation.

Franck Toussaint is founder of the global association Bio Supply Chain Management Alliance with presence in Europe, USA and India. Franck is also managing Biolog Europe, a non profit excellence center in Life Science Supply chain. Franck has a 20 years experience in the industry and conducted with success all over the world a couple hundred consulting missions in supply chain and logistics for Pharma & biotech organisations or international organisations, World Bank, some governments, airports or other key stakeholders. Previously Franck worked with WBC ventures, a dedicated life science incubator and venture fund. He is also recognized as life science expert by the Belgian government.

Dr. Erik van Asselt is working for more than 20 years in the pharmaceutical industry with strong experiences in Temperature Controlled Distribution, Data Integrity, Quality Risk Management, Lean Six Sigma, Packaging, and Stability Testing. He is a professional with a Doctor of Philosophy (Ph.D.) in Protein Crystallography from University of Groningen. Since 2009 he chairs the PDA Pharmaceutical Cold Chain Interest Group (PCCIG) - European Branch. In this role, he acts as frequent speaker at conferences and training courses, and writer of technical reports and articles about cold chain management, stability budget, last mile, and active/passive temperature-controlled transport.