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Visit us in booth #946!

Tech talk: Top 10 Regulatory Rules for Successful Submissions
When: September 26th at 11:30am
Where: Tech Theatre

 

Visit us in booth #1678

Booth #804

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. We will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, FDA guidances & other international regulatory requirements for best practices in materials and chemistry characterization for drugs, biologics, delivery systems, and primary & secondary packaging.

SPEAKER HIGHLIGHT

Ted Heise, PhD, RAC
Vice President, Regulatory and Clinical Services

Topic: Medical Device E&L: Latest Activities of ISO/0000TC 194/WG 14
When: Tuesday, April 18th at 11:10am

Limulus Bio is proud to present Biocompatibility Matters 2022, a two-day conference in Copenhagen created to bring you networking opportunities, speakers that guarantee scientific height and valuable industry insights regarding changes in requirement and case studies.

Conference Day 1 October 5th, 9am – 5pm
Understanding the device: Chemical Characterization (ISO 10993-18)

Ted Heise, PhD, RAC, Vice President of Clinical and Regulatory at MED Institute, will speak about the current considerations for establishing a practical AET – incl. solvent exchange, concentration, and pooling.

Ted Heise, PhD, RAC, Vice President of Regulatory and Clinical Services, will be a panelist on this upcoming webinar.

What will attendees learn?

• What’s required by FDA to get into an IDE trial: Hint: robust design history files, and answers to questions that validate or confirm clinical hypotheses.
• What clinical trials need to answer in order for the greatest potential for regulatory approval. Hint: key players include regulatory associates, internal review boards, contract research associates and design history file team members.
• Clarity on pathway to regulatory approval in clinical use and broad patient populations.

Who should attend?

• Early stage medical device and technology companies
• Academic investigators
• Physician entrepreneurs
• Clinicians interested in participating in clinical studies
• Investors in new medical technologies who want to ensure capital efficient design, development and regulatory approval pathways for their invested companies

Visit us at OMTEC June 14 – 16, 2022 in booth #636!

Visit us April 12-14, 2022 in booth #2896!

Don’t miss our tech talk, “Particulate and Medical Devices: Past, Present, and Future”, taking place Tuesday, April 12th at 12:30pm in the Tech Theatre.

 

Ted Heise, PhD, Vice President Regulatory & Clinical Services

Extractables and Leachables in Chemical Characterization Roundtable

Tuesday, September 28, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST