This presentation will:

• Provide an understanding of current FDA regulatory trends
• Allow an understanding of how to navigate the ever-evolving U.S. regulatory landscape
• Examine proven, time-tested strategies and frameworks that lead to accelerated regulatory approvals for any device type

Topics to be covered:

Global Regulatory Pathways – Plan For Successful Submissions

• Learn how to avoid common mistakes, as well as some helpful tips of the trade for regulatory submissions.
• How can you manage the market clearance process without becoming victim to common pitfalls?

FDA Trends & Guidance for Industry
With a new Medical Device User Fee Act in its fourth iteration, a series of changes from the FDA are expected over the next five years. Likely shifts include:

• Shorter approval decision times
• More patient involvement,
• Increased utilization of real-world evidence
• Broader trends in government, technology, and society will directly drive new requirements within the medical device industry

Presenter: Carla Wiese
Carla Wiese is a principal medical research scientist at NAMSA. Prior to working at NAMSA Carla was at the FDA serving as a lead reviewer and engineering consultant in the Division of Cardiovascular Devices for 3 ½ years and the program lead for the Early Feasibility Studies program for the last year and a half. Carla also worked as a research and development engineer in industry for over a decade in both a large company and a startup.

Who Should Attend?

• Regulatory and Quality Staff
• Medical Device Development and Manufacturing

Don’t miss the Spring Social! 
Directly after the education session, the LSPA Spring Social will be taking place at the same venue!  Relaxed, casual networking with approximately 300 life science professionals.

• Purchase a ticket for both events and recieve a $25 discount.  Go to Tickets to purchase.

Want to Exhibit? Contact Melissa Irwin mirwin@lifesciencespa.org.

Life Sciences Pennsylvania’s Spring Social is an annual gathering of 300 life sciences professionals for relaxed and casual networking. It has been rated as Life Sciences Pennsylvania’s top networking opportunity of the year.  Thirty to forty organizations will exhibit at the event, with tables spread throughout the room.  

The Spring Social is designed for everyone from the CEO at a large pharmaceutical company to the accountant at a small marketing firm. This much-anticipated event is an excellent opportunity to mix and mingle with your life sciences colleagues before heading off to enjoy summer vacation.

The hallmark of advocacy is the ability to tell your story.  You don’t need to study public policy or be up-to-date on the latest policy debates to be effective.  You simply need to have a concise description of your company, demonstrate your passion for innovation, and explain who it will help.  Realizing that most legislators are not regularly exposed to the life sciences and are not scientists (we only have one in the entire legislature of 253), this is your opportunity to educate and inform.

Each year Life Sciences Pennsylvania provides a platform for our member companies to come to Harrisburg, receive a briefing on the latest issues, and attend meetings with key legislators and staff.You don’t need to know your way around the capitol building, we’ll have group leaders to guide you along the way.  And by the way, everyone who attends thinks it is a fun way to spend a day.

The impact of the meetings is seen almost immediately as these policy makers are more knowledgeable about your company, its role in Pennsylvania’s life sciences community, and they learn about the promise your drug, therapy, medical device, or diagnostic holds for future patient care.
So be there and tell your story.  Your voice is needed in the halls of Harrisburg.
The event is free. Breakfast and lunch will be provided.

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.

The key benefits of attending the 2018 BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry though-leaders with over 500 education sessions at your fingertips, and unparalleled networking opportunities with 16,000+ attendees from 74 countries.

• Program Topics and Speakers
• Promotions and Communications
• Symposium: Partnerships in Science
• Funding Resources
• Company Presentation