This webinar will provide for the effective use of regulatory tools such as: Manual of Policies & Procedures, guidance's, and ICH Common Technical Documents, to achieve the correct pathway for submitting an ANDA for review and approval by the US Food and Drug Administration (FDA).
Learning Objectives:
- Refusal to file or receive
- cGMP certification or Approved facility
- Basic QBD issues; Pharmaceutical development reports
- Drug Master files
- Inactive ingredients discussion; (Inactive Ingredients Database)
- Active ingredients; Module 3 recommendation (21 CFR 314.420(a)(2)
- Inactive ingredients discussion; (Inactive Ingredients Database)
- Drug product manufacturing; bill of materials, batch records instruction (including critical steps)
- Test specifications; USP, ICH, Certificates of analysis
- Impurity profile and Stability program
Why Should You Attend:
The training will benefit those involved in the development and manufacture of pharmaceuticals, as well as, those preparing CMC documents for submission to regulatory agencies. This webinar will help you in identification of critical elements (data) that are required to support a successful submission to the Office of Generic Drugs.
Topic Background
Twenty-five years ago, Congress enacted the Drug Price
Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman
Act1 (hereinafter "Hatch- Waxman")-the cornerstone for competition between brand
and generic pharmaceutical companies. Hatch-Waxman amended the Federal Food,
Drug and Cosmetic Act (FDCA) 2 and the Patent Act 3 and achieved a sensitive
balance between patent protection and encouraging generic entry.
Hatch-Waxman established the abbreviated new drug application (ANDA) process
that requires generic manufacturers to demonstrate that the generic is
"bioequivalent" to an approved brand drug. Thus, it is imperative that all
applicants follow requirements as posted by the USFDA and dictated in the ACT.
Instructor
Mr. Lamont M. Fulton is President of Regulatory Direction LLc and has overForty years of Pharmaceutical experience (26 inregulatoryaffairs CMC).Mr. Fulton has had roles as both Manager and Director of Chemistry Manufacturing and Controls (CMC) Regulatory and labeling at both Branded(Merck, SmithKline, Wyeth) and Generic drugs firm (Mylan).
Prior to working as the leader to regulatory affairs departments, Mr. Fulton worked at the FDA as a Chemist reviewer in the center for drugs. While at the FDA, He also worked as anAnalyst in the office of regulatory affairs and international office of policy, dealing with FDA/ICH regulations and guidance for global initiatives.
Mr. Fulton's past experience in government and industry, including his current role as senior consultant, has allowed him the opportunity to develop relationship with various CMC partners(Pfizer, Johnson and Johnson, Bristol Myers Squibb, etc.).
It has also afforded his consultancy the chance to assist and manage other multidisciplinary teamsachieve approval fordozens ofNDA's, ANDA's to the FDA, as well as provide help with several successful international drug applicationsto the EMEA, MHLW and ROW.
The blended years of both pharmaceutical quality and regulatory affairs has provided Mr.Fulton with a perspective to determine appropriate filing strategy and provide regulatory impact of changes in postâ??marketing products.
Mr. Fulton has BA degree in Chemistry from Cheyney University of Pennsylvania; where he studied under Dr.Taylor on the nature of terpenes and its various derivative. Certificate of Pharmaceutical training from University of Maryland school of Pharmacy / FDA program.
Mr. Fulton's affiliations included; GPhA (Generic Pharmaceutical Association), ACS American chemical society) RAP (Regulatory Affairs Professional society), PDA (Parenteral Drug Association); Sigma Xi.