Archives: Speakers

Ensures that processes related to clinical documentation and training, meet
quality/regulatory standards. Develops proactive strategies to implement GCPcompliant processes. Monitors and assesses clinical trial disclosure requirements,
to ensure that the department is covered by adequate procedures and systems for
training and that training is delivered in accordance with Department needs,
Company’s policies and SOPs; support during Inspection/Audit; to support the
Study Team to ensure a complete and accurate TMF through documentation
quality and consistency; to develop TMF culture through all the clinical process and
ensure the implementation of the eTMF.

his position participates in tactical & strategic planning to develop a state-of-the-art labeling design organization. Lead initiatives related to development and implementation of design systems in preparation for upcoming product launches and ongoing commercial operations. Work with functional groups including Regulatory Affairs, Quality Assurance, Commercial, Legal, Packaging Engineering, and Manufacturing to further refine the process for design & development of clinical and commercial labeling. Work with Commercial and Regulatory to develop and finalize graphic elements and product branding elements of labeling for EU, US and ROW. Develop estimates for labeling component printing quantity and cost requirements to support needed clinical and commercial activities. Review and approve packaging artwork for accuracy, regulatory requirements and production requirements. Lead drafting, review, update (as needed) and approval of function SOPs. Identify, develop and lead opportunities for continuous improvement for deliverables and processes. Lead sub-groups and teams as required to assist in product launches. Evaluate capabilities and capacities of current or proposed suppliers. Work with bluebird bio’s Supplier Relationship Management & Quality teams to qualify and on-board labeling/packaging suppliers. Participate in technical supplier audits. Be single point of contact for suppliers and coordinate with cross functional team to review and resolve supplier service performance expectations to ensure bluebird bio requirements are being met. Work with Finance team to create/maintain label design budget, PO creation and invoice payments. Lead design activities for creating labeling/packaging artwork, preparing associated specifications, managing related electronic labeling systems and quality systems and coordinating printing for both clinical and commercial labeling.

Responsible for developing EU MDR localization strategies across Medtronic businesses and functions. Engaged in development of industry guidance related to interpretation of EU MDR requirements. Focused on implementing efficient localization strategies that result in high quality, consistent localized content that meets the requirements of notified bodies and provides clear information to all end users including healthcare providers and patients.

Chris Bosse founded LAVA in 2007 with Tobias Wallisser and Alexander Rieck. This international network of leading architects uses the latest research and technology to build efficient, sustainable beautiful structures.

Educated in Germany and Switzerland, Bosse bases his work on the computerised study of organic structures and resulting spatial conceptions.

His award-winning design projects have won Bosse an international reputation as a new generation architect who pushes the boundaries of traditional structure and architecture by digital and experimental form-finding.

Whilst Associate Architect at PTW in Sydney Bosse was a key designer of the Beijing Olympics Watercube, winner of the Atmosphere Award at the 9th Venice Architecture Biennale and the AIA Jorn Utzon Award for International Architecture. The following year he received the Emerging Architect RIBA award, in 2012 Perspective’s 40 Under 40 for Asia’s rising design stars and an Australian Design Honour in 2015.

LAVA was the 2016 Laureate of the European Centre for Architecture Art Design and Urban Studies and The Chicago Athenaeum: Museum of Architecture and Design.

Alongside his architectural practice Bosse is Adjunct Professor at the University of Technology, Sydney and lectures worldwide.

Heather Haselmann has been with Canfield since 2005.  She started as Project Manager and grew to role of Associate Director of Clinical Services overseeing project teams.  This led her to current role as Director of Business Development in which she is able to speak to the team’s expertise and create solutions for their clients.  Heather is responsible for communicating the breadth and depth of clinical project management services, ensures customer service provided at the highest levels, including proposals and follow through of deliverables.  Heather has extensive knowledge of the industry which covers Dermatology, from hair growth to onychomycosis and skin conditions, Aesthetics, Body Contouring, Oncology and Rare Diseases related to skin.

Chris is an experienced consumer insights specialist who works day-to-day with global clients across the Food & Beverage, Home Care and Personal Care categories to inform their Innovation, Strategy and Marketing decisions using social data and trend prediction methodologies.

Phil has spent a career driving business impact from data & insight, having led teams, clients and business units in and across developing and developed markets. Phil has operated both agency side, and client side, including ten years at PepsiCo in a variety of insight, customer strategy and commercial roles. At Black Swan Data, Phil leads our team of insight professionals, using big data and predictive analytics to help clients drive advantaged category strategies, innovation and brand positioning.