22 - 24 October, 2019 | Mercure Hotel MOA Berlin, Berlin, Germany
Main Conference Day One
8:30 am - 8:55 am Registration and Coffee
8:55 am - 9:00 am PharmaIQ Welcome
9:00 am - 9:10 am Chairwoman's Opening Remarks and Welcome
Susan Neadle
Head, Combination Products CoP and Sr. Director, Global Value Chain Quality DesignJohnson & Johnson
9:10 am - 9:30 am Speed Networking
A highlight of Pharma IQ events! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers. There is a prize in it for the winner, so, get networking!
Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge
9:30 am - 10:10 am Integrating Post-Market Surveillance Throughout The Lifecycle
- Understand why it’s important to interlink post market surveillance into all stages of the lifecycle
- Identify why internal communication strategies are crucial for effective lifecycle management
- Learn the best practices to prepare for the EU MDR
10:10 am - 10:40 am Networking Coffee Break
10:40 am - 11:20 am Nonclinical Safety Requirements For Registration Of DDCP
- Understanding the complexity of nonclinical safety requirements for DDCP
- Discover how to perform biocompatibility testing according to ISO-10993
- Select an appropriate test strategy to avoid potential pitfalls
11:20 am - 12:00 pm Combining MDR regulation requirements and market adoption
- Hone in on post-MDR peer review evidence throughout your device lifecycle
- Improve your study publications from pre-clinical to post-market
- Create an evidence based strategy throughout the lifecycle of the device thanks to teams cross functional collaboration in order to facilitate market adoption and fulfil MDR requirements
Patrice Becker
Global Director Scientific Communications / Surgical Innovations Medical AffairsMedtronic
12:00 pm - 1:00 pm Networking Lunch
1:00 pm - 1:40 pm Regulatory Intelligence: Influence on Strategy Development
- Explore how you can take your combination product beyond the US and EU markets
- Understand the differing submission requirements for combination products in countries such as China, Malaysia and South Korea
- Identify the documentation must be submitted in order to remain compliant
- Understand how regulatory intelligence can be incorporated into your product and processes
1:40 pm - 2:20 pm Regulations: A Notified Body Perspective
- Analyse the MDR and its impact on medical device manufacturers and the pharmaceutical industry
- Gain insight into Notified Body interpretations of Article 117 and expectations for manufacturers
- Understand the impact of additional Notified Body scrutiny during the conformity assessment
2:20 pm - 2:50 pm Networking Coffee Break
2:50 pm - 3:40 pm Roundtable Discussions:
Use this opportunity to benchmark with your peers and identify the key strategies required to optimise your lifecycle management process, from concept to market. Use this 40 min opportunity to discuss your chosen topic and benchmark with your peers.
- Lifecycle management and registering products across the globe
- How to structure the regulatory submission
- Challenges to the implementation of Article 117 under the MDR
3:40 pm - 4:20 pm UK Notified Body: Brexit and EU MDR 2020 Challenges
- Address the ongoing conformity assessments for new devices/line extensions/manufacturers in application
- Look at the future of consultation conducted by UK competent authority for devices with ancillary medicinal substances
- Cover Notified Body designation, new requirements under the MDR and legacy products
- Identify best practices for early renewal under MDD to have market access for limited time post May 2020
Tina Amini
Independent Technical and Regulatory ConsultantCombination Products, Medical Devices & Quality Systems
4:20 pm - 4:30 pm Chairwoman's Summary and End of Day One
Susan Neadle
Head, Combination Products CoP and Sr. Director, Global Value Chain Quality DesignJohnson & Johnson