SUBJECT: REGULATORY LANDSCAPE FOR PHARMA MANUFACTURERS
AMSTERDAM, 30-Mar-2016 — /EuropaWire/ — Christoph Krähenbühl, senior director, 3C Excellis, will be a featured speaker at Systech International’s upcoming global conference in Amsterdam titled UNIQUITY Europe, 2016, focused on serialization, global brand protection and consumer safety.
Krähenbühl is an expert on global serialization and tracing regulations. Serialization regulatory deadlines have either passed or are approaching in four of the top five pharmaceutical markets in the world with more being established each year.
With several EU countries planning new implementation requirements, manufacturers and packagers are required to implement unit-level traceability now, while still planning their migration to aggregation capability as the next phase of regulations become effective.
Krähenbühl has been involved in serialization Projects since 2006, lately as Product Security Manager at AstraZeneca, who were one of the early adopters and global leaders in pharma serialization.
“The pharmaceutical industry is facing a tremendous challenge to quickly comply with the European Medicines Agency’s (EMA) plans to implement packaging safety features as part of the Falsified Medicines Directive (Directive 2011/62/EU) (FMD), adopted in July of 2011,” explains Manfred Voglmaier, senior director, Europe, Systech International.
“Christoph speaks to the fact that they need to ramp up now if they are to meet the requirement for serialization of licensed drug products, which will be a legal requirement for companies in the EU starting in 2019.”
In 2012, Krähenbühl co-founded 3C Integrity with industry expert Ian Haynes, specializing in consulting and training in pharma serialization. In January of 2016, they combined with Excellis Health Solutions to form 3C Excellis Europe. 3C Excellis’ core business is to support pharma companies – brand owners, generic manufacturers, contract packers, from large enterprises operating world-wide to CMO and small specialized companies – in shaping up, planning and delivering their serialization programs.
“Christoph’s area of special expertise is the regulatory requirements landscape, particularly in Europe where he worked on the original EFPIA team that led to the EU-FMD requirements and is currently working for the EMVO (European Medicines Verification Organization) to support the engagement of the member states in the roll-out program,” said Voglmaier. “As such, he has an unparalleled understanding of global regulations and how to meet them using technology.”
UNIQUITY Europe is a two-day conference providing the latest insights, resources, tools and networking opportunities for customers, industry leaders and equipment manufacturers. The program includes speakers, presentations, panel discussions and workshops on best practices and strategies, as well as hand-on training and demonstrations of serialization and track and trace software.
For more information or to register, please visit http://systechone.com/uniquity2016eu/.
About Systech International
Systech is the global technology leader in product safety, and consumer and brand protection. Systech pioneered serialization and is defining the future of authentication.
Trusted by 19 of the top 20 pharmaceutical companies, Systech unifies and optimizes enterprise serialization, track and trace, and authentication technologies to ensure regulatory compliance, mitigate risk, and drive efficiency and profitability.
For 30 years, Systech’s innovation has led best practices for key brands across the pharmaceutical, life science, food and beverage, and consumer packaged goods industries.
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