Workshops & Lectures
 seminars / workshops for pharmacovigilance

Synergy Research conducts frequent seminars and workshops for the life science industry.  Below please find our current calendar of events.

Workshop and Lecture Series

Upcoming Workshops and Lectures provided by 

Synergy Research Inc.

 

510(k) Exempt or not Exempt

Mario Guralnik, PhD, Erin Baruch, MD 

  • Workshop on navigating the FDA Medical Device Program

  • What options are really available

  • DeNovo !  

  • When do I submit


GMPs for Early Clinical Trial Programs 

Mario Guralnik, PhD, Yvette Yamanouci, PhD

  • Meaning of A Phased Approach

  • Does my Phase I Qualify

  • cGMP Statutory Requirements and the IND Program


Medical Foods

Mario Guralnik, PhD 

  • Where do they fall?

  • What does that mean in IND land?

  • Clinical Trial Requirements

  • Can my local acting gum be a medical food?


Device Development Workshop
Mario Guralnik, PhD, Yvette Yamanouci, PhD, Erin Baruch, MD 

  • Regulatory Strategies

  • Clinical Development Plans

  • Reimbursement Studies


Good Clinical Practice; Site-to-Sponsor

Mario Guralnik, PhD, Erin Baruch, MD 

  • IRB Requirements Workshop

  • The Modern Protocol

  • Data and More Data; Dealing with Case Report Forms

  • Sponsor-CRO Integration

505(b)(2) Development Umbrella

Mario Guralnik, PhD

  • Find out if our product has a life under the 505(b)(2) umbrella

  • What are the truths and myths about 505(b)(2) drug development programs

  • When to ask the FDA;  What to ask the FDA


The Pre-IND Process

Mario Guralnik, PhD, Yvette Yamanouci, PhD 

  • What to do about nothing:  What happens when FDA refuses to provide a pre-IND meeting

  • What you shouldn't ask can be more important than what to ask

  • My briefing package:  What that should look like