Regulatory affairs teams play many key roles throughout the drug development process—providing strategy and insight to clinical development, medical affairs, and marketing to improve efficiencies and ensure compliance at every stage.
Regulatory Affairs often requires collaboration with various country-wide and regional regulatory authorities and company international affiliates. Because compliance is such a high-stakes and important part of the entire lifecycle of a drug, it is critical for industry professionals in any functional area to master a foundation of regulatory affairs knowledge to help them succeed. FRAMEwork is here to help!
This module covers the purpose and jurisdiction of regulations governing drug approvals and use, responsibilities of the FDA, examination of key elements of IND and NDAs, and key legislation that has improved the efficiency of drug approvals.
This module covers the regulatory framework for prescription drugs and promotional materials by examining key FDA regulations and challenges involved in producing compliant prescription promotional materials.
This professional development program will benefit all student pharmacists preparing to apply to industry fellowships and experienced practicing pharmacists [who are preparing to transition to industry] regardless of functional area.
YOU WILL HAVE ACCESS TO THE WEBINAR FOR 6 MONTHS, BEGINNING ON YOUR DATE OF PURCHASE!
Still a guest? Upgrade your status today! Click here to learn about the benefits of membership and sign up today!
Jerry Silverman, BS Pharm
Senior Coach and Industry Instructor, IPhO
Namosha Mohite, PharmD
Global Regulatory Strategist, Bayer
Leah Palmer, PharmD
Former Executive Director, Regulatory Promotion Compliance, Amgen
Regulatory Promotion Consultant
