Following on from day 1, the sessions on day 2 of Pharmaceutical and Medical Device Packaging and Labelling 2015 in Berlin will continue to discuss the biggest challenges and regulatory issues within their packaging and labelling processes.

The event sessions on Thursday 10th September will provide a unique opportunity for leading representatives from the pharmaceutical and medical device industries to explore compliance strategies and implementation. The programme has been organized to include a variety of discussions, presentations and round tables.

8:30-09:00 Registration and refreshments

09:00-09:30 Establishing ISO norms for green packaging and identifying options for alignment in development of environmental products

Horst Kastrup, Senior Advisor, Meda Pharma

• Navigating environmental norms to optimize sustainability in packaging materials
• Identifying relevance of ISO standards to pharmaceutical packaging to establish goals for a green supply chain
• Anticipating challenges in company compliance with ISO standards to determine objectives for an environmental outlook in future
• Creating a workable format for compliance with ISO standards to enhance sustainability and reduce costs
• Recognising future for green packaging to establish the role it will likely play and identify strategy for observance of ISO standards

09:30-10:00 Promoting practical compliance with e-labelling legislation to ensure successful recognition of regulations now and for the future

Simon Richards, VP, Regulatory Affairs, EME - Alere

• Deciphering current scope of e-labelling to identify company needs to ensure compliance
• Proposing methods of supplying e-labelling to ensure regulatory compliance
• Decoding e-labelling around the globe to ensure a coherent international strategy
• Anticipating future of e-labelling to ensure long term approach to compliance

10:00-10:30 Exploring J&J’s processes for accurate and efficient translation across borders for medical devices to ensure success in diverse territories such as Eastern Europe, China and Russia

Anna Kolankiewicz, Senior Manager Quality & Regulatory Compliance, CEE, Russia & CIS, J&J

• Outlining challenges in translation in upholding quality through effective management to ensure correct implementation across all languages
• Appreciating difficulty in providing effective product information to countries with multiple native languages with limited leaflet space while remaining compliant with regulatory needs to ensure readability
• Considering procedures for compliance with labelling legislation across several regulatory bodies to maintain global standards
• Outlining available approaches to translation needs, including human and software tactics, to establish most effective method for your company
• Establishing accuracy and regulatory compliance while appreciating differing patient needs of leaflets in different regions

10:30-11:00 (to be confirmed)

11:00-11:30 Morning refreshments and networking

11:30-12:00 Analyzing requirements for E-labelling of medical devices and possible strategies for implementation

Holger Most, Regulatory Affairs Lead EMEA,GE Healthcare Information Technologies GmbH & Co. KG

• Addressing current regulations surrounding E-labelling for medical devices to identify current regulatory expectations
• Navigating your need to improve information provision for your medical device to create an optimal strategy for your company
• Exploring challenges associated with E-labelling when future is still uncertain to enhance approach
• Utilizing E-labelling as a strategy to avoid excessive information required on leaflets to reduce size of packaging allowing for greater information delivery
• Assessing benefit of incorporating E-labelling in to a sustainability programme

12:00-12:30 Exploring UDI: The data gathering and maintenance challenges

Inge Ørnhøj, Senior Process Improvement Manager; Bianca Greve, Senior Regulatory Affairs Manager, Coloplast

• Defining roles and responsibilities in GUDID account and setting up the account
• Overviewing GUDID data – exploring main challenges in gathering data and making it extractable
• Assessing Master Data Governance: The roles within Regulatory Affairs and Supply Chain
• Defining how to control data maintenance
• Handling submissions to GUDID
• Challenges in relation to the expected European UDI legislation

12:30-13:00 (to be confirmed)

13:00-14:00 Lunch and networking

14:00-15:30 Speaker hosted round table sessions

• Analysing approaches to tamper-evidence packaging to outsmart the counterfeiters - Hanna Bruun
• Discussing global regulatory requirements for serialization to establish challenges and strategize solutions - Roland Pitsch
• Examining role of packaging and labelling in patient compliance - Cornelia Hain
• Identifying current challenges in e-labelling to determine its future - Lydia Kaiserer

15:30-15:45 Chair's summary and close of conference