President at OPD Consulting Group
As a board certified physician with over 30 successful years in the biopharmaceutical and medical device industry Bart Chapman MD MBA has been involved in approved NDAs, BLAs and PMAs and directing clinical trials through all phases.
His role has varied from developing Phase I-IV protocols and implementing them to overseeing strategic marketing and regulatory compliance. He has been involved in designing and implementing MOPS which have included integrating protocol design and phase I- IV implementation with the launch and marketing of approved products.
Dr. Chapman has secured sophisticated SABs as well as participated in numerous leadership roles as both physician investigator as well as physician advisor for the development of ocular, infectious disease, diabetes, oncology and medical device therapeutics. As a medical director and regulatory consultant, he has been responsible for the following:
- Developing g strategies for identifying product safety concerns
- Protocol development
- Optimizing clinical efficiency using adaptive research methods
- Meeting FDA and EU regulatory guidelines for NDA, PMA, BLA approvals
- Safety labeling changes
- Standardized AE/SAE formats/AERS
- Impact assessments
- Communication strategies regarding safety
- Communications and responses to regulatory authorities
- Mitigation strategies
- Phase I-IV safety issues
- Orphan drug and medical device regulatory requirements
As both an employee as well as a consultant to numerous pharmaceutical companies from Fortune 100 companies to small biotech companies, Dr. Chapman has a successful track record in developing strategic plans. In the process he has designed and implement GLP and GMP facilities.
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