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Events and Networking

Expand Your Network at One of Biocom’s 150+ Annual Events

Modified Release Solid Oral Dosage Formulations and Regulatory Considerations

When:

Wed Apr 18 15:00:00 GMT 2018 - Wed Apr 18 17:00:00 GMT 2018

Where:

Biocom - McGraw Conference Room
10996 Torreyana Road Suite 200
San Diego, California 92121

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The presentations will review the technical formulation differences between Immediate release and Controlled (modified) release solid oral formulations with an emphasis on formulation approaches for Modified Release, including reasons for changing from immediate to modified release and how to go about this change from a technical perspective.  Discussions will provide Regulatory considerations for Modified Release formulations including the most common regulatory pathways for approval with comparison and contrast for each option.

Speakers: 

  • Dr. Myke Scoggins, Process Development manager at RECRO Gainesville, LLC.
  • R. Wayne Wiley, Senior Director of Regulatory Affairs at RECRO Gainesville LLC.

Price of Admission

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Today's Price: 25.0

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25.0

Refund before Tue Apr 17 00:00:00 GMT 2018

25.0

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*Refunds will no longer be accepted after

  • Speaker Bios

    Speaker Bios: 

    Dr. Myke Scoggins earned his BS in microbiology from the University of Georgia and PhD in Pharmaceutical Sciences from Mercer University. He has nearly 25 years of experience in the pharmaceutical industry, including analytical chemistry, preformulation, formulation, process development and validation, scale-up, tech transfer, and manufacturing support. Prior to joining Recro, Dr. Scoggins worked in other pharmaceutical development environments on various dosage forms and delivery systems including tablets, capsules, transdermals, microneedles, and osmotic systems. He has  experience in analytical instrument manufacturing,  management of medical device  microbial and chemical testing, NDA and ANDA development for FDA and international filings , and a past history of  Pharma research  at the Georgia Institute of Technology. He has delivered numerous lectures on topics in the pharmaceutical sciences to graduate students, helped develop graduate courses in pharmaceutical sciences, and he has presented research findings at national and international meetings. Dr. Scoggins is currently a member of AAPS, and sits on the USP Expert Committee for General Chapters – Physical Analysis with memberships on the Powders and Particles Sub-committees and the Nanotechnology Joint Sub-committee. He is currently Process Development manager at RECRO Gainesville, LLC.

    R. Wayne Wiley is a graduate of Mercer University School of Pharmacy and a Registered Pharmacist. He has over 30 years of experience in Pharmaceutical Regulatory Affairs including over 20 years in Drug Delivery Specialty Pharma. He has experience in Regulatory Agency meetings as well as NDA, ANDA and international application approvals. Wayne is a member of RAPS, DIA and AAPS and he has given lectures in Regulatory Affairs and Pharmacovigilance for the University of Georgia Masters in Pharmacy degree program and serves on the Admissions Committee.  He has also provided support for Mercer School of Pharmacy Doctor of Pharmacy Preceptor training. He is currently Senior Director of Regulatory Affairs at RECRO Gainesville LLC.

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  • Speaker Bios

    Speaker Bios: 

    Dr. Myke Scoggins earned his BS in microbiology from the University of Georgia and PhD in Pharmaceutical Sciences from Mercer University. He has nearly 25 years of experience in the pharmaceutical industry, including analytical chemistry, preformulation, formulation, process development and validation, scale-up, tech transfer, and manufacturing support. Prior to joining Recro, Dr. Scoggins worked in other pharmaceutical development environments on various dosage forms and delivery systems including tablets, capsules, transdermals, microneedles, and osmotic systems. He has  experience in analytical instrument manufacturing,  management of medical device  microbial and chemical testing, NDA and ANDA development for FDA and international filings , and a past history of  Pharma research  at the Georgia Institute of Technology. He has delivered numerous lectures on topics in the pharmaceutical sciences to graduate students, helped develop graduate courses in pharmaceutical sciences, and he has presented research findings at national and international meetings. Dr. Scoggins is currently a member of AAPS, and sits on the USP Expert Committee for General Chapters – Physical Analysis with memberships on the Powders and Particles Sub-committees and the Nanotechnology Joint Sub-committee. He is currently Process Development manager at RECRO Gainesville, LLC.

    R. Wayne Wiley is a graduate of Mercer University School of Pharmacy and a Registered Pharmacist. He has over 30 years of experience in Pharmaceutical Regulatory Affairs including over 20 years in Drug Delivery Specialty Pharma. He has experience in Regulatory Agency meetings as well as NDA, ANDA and international application approvals. Wayne is a member of RAPS, DIA and AAPS and he has given lectures in Regulatory Affairs and Pharmacovigilance for the University of Georgia Masters in Pharmacy degree program and serves on the Admissions Committee.  He has also provided support for Mercer School of Pharmacy Doctor of Pharmacy Preceptor training. He is currently Senior Director of Regulatory Affairs at RECRO Gainesville LLC.

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