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BIOTE-220 Introduction to Regulatory Affairs for Biotechnology Professionals
Fall 2013
Monday, 7:40 - 9:40 PM, Science Center 110
Instructor(s): Virginia (“Ginny”) Garcia
Prerequisites: No prior coursework is required. However, given that all of the materials for this class are in the public domain, internet access is REQUIRED.
Instructional Staff
Virginia (Ginny) Garcia, MPP, RAC
Email: virginiatma@yahoo.com
Phone: 617-835-
Course description
This course is designed to examine and discuss the role of Regulatory Affairs in the Biotechnology industry. Each session is two hours long.
The Regulatory Affairs (RA) environment encompasses the regulations and standards governing product development through post-approval marketing. In today’s regulatory environment, biotechnology products may be classified as drugs, biologics, medical devices, or combination products. In almost every country in the world, each type of product is regulated by a different entity and often has its own distinct regulations. Focusing on the US and European Union (EU) framework, this course provides an overview of RA and how the regulatory environment can shape product development. Course topics include: RA history, regulatory agencies, accessing regulatory information, drug submissions, biologics submissions, medical device submissions, Quality System Regulations (QSR) Good Laboratory Practices (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
Readings are drawn from government regulations and guidance documents. The main focus of the course is to introduce students to the role of Regulatory Affairs and the various interactions with medical product design/project teams, global health agencies and trade associations.
Course Objectives
Students in biotechnology developing medical products need an understanding of the regulatory process governing the development and launch of medical products. This course is designed to present an introduction to the regulations and documents necessary for US and outside US (OUS) approval of a medical product. The student will be introduced to US FDA and EU regulations, clinical trial regulations and guidance documents as well as submission requirements. Other geographies (such as Canada and Japan) will be briefly reviewed. The goal of this course is to prepare the biotechnology professional to interact with Regulatory colleagues by asking the right questions and providing information in a manner to facilitate regulatory compliance.
While this course focuses on helping biotechnology professionals interact effectively and efficiently with regulatory colleagues, another main objective is to help each student develop and enhance his or her research and presentation skills. We examine the structure of the regulatory framework for medical products, how to identify potential regulatory questions or concerns, and how to successfully interact with and support colleagues and documentation involved in regulatory filings and compliance activities.
Course Policies and Expectations
Attendance and class participation is imperative to success. A two-person approach to presentations will be permitted if class enrollment exceeds 16 students.
Materials and Access
There are no required texts for the course. Internet access is required for this course. Reading assignments will be from on-line publications or on-line regulations. Links to the readings will be available on the syllabus before they are to be discussed. Students are expected to read the specified materials and prepare any assignments before coming to class.
Although there is no textbook for this course, the following are detailed texts used by Regulatory Affairs Professionals to prepare for certifications: RAPS Fundamentals of US Regulatory Affairs; Fundamentals of EU Regulatory Affairs; Fundamentals of International Regulatory Affairs (each approximately $300). It is not necessary to purchase these books.
A- ≥ 90.0%
B+ ≥ 86.6%
B ≥ 83.3%
B- ≥ 80.0%
C+ ≥ 76.6%
C ≥ 73.3%
C- ≥ 70.0%
Academic Integrity
PLAGIARISM:
Any material submitted to meet course requirements—homework assignments, papers, projects, examinations — is expected to be a student’s own work.
The final responsibility for knowing proper forms of citation rests with the student.
COLLABORATION:
Collaboration in the completion of assignments is prohibited, however, the instructors may allow collaboration for final presentation and/or paper if class size is larger than expected. If collaboration is necessary, students will be assessed based on demonstrating their understanding of the regulatory requirements for medical products and cohesiveness of written paper and/or presentation. Students are expected to acknowledge any collaboration and its extent in all submitted work.
Accommodations for students with disabilities
Students needing academic adjustments or accommodations because of a documented disability should reference http://www.extension.harvard.edu/resources/disability-services and speak with the professor by the end of the second week of the term.
Course Schedule
NOTE: Reading and discussion requirements are detailed in the Course Materials section of the course website ( http://isites.harvard.edu/icb/icb.do? keyword=k97396&pageid=icb.page607500 ).
Week Date Topic Discussion
1 9-Sept Introduction to Regulatory Affairs Professionals: Who are they and why do they ask so many questions?
- FDASIA (http://www.fda.gov/ RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActF DCAct/ SignificantAmendmentstotheFDC Act/FDASIA/ucm20027187.htm)
- Regulatory Science at FDA (http:// www.fda.gov/ScienceResearch/ SpecialTopics/RegulatoryScience/ default.htm)
- Laws, Regulation, Guidance, and Standards; Introduction to ISO, ICH, USP (http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123804.htm)
- Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards (http:// www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ ucm077274.htm)
- Acronyms and abbreviations ( http://www.accessdata.fda.gov/ scripts/cder/acronyms/index.cfm)
2 16- Sep
US: Drugs Part I • What are drugs?
- PDUFA (http://www.fda.gov/ ForIndustry/UserFees/ PrescriptionDrugUserFee/ default.htm and http:// www.fda.gov/ForIndustry/ UserFees/ PrescriptionDrugUserFee/ ucm272170.htm)
- Bad Ad Program and the most recent 2011-2012 Year End Report (http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInf ormation/Surveillance/ DrugMarketingAdvertisingandCom munications/ucm258719.htm)
- FOR CLASS DISCUSSION: Pick a drug that you are familiar with and research it in the Orange Book. Be prepared to discuss one entry from the Orange Book.
4 30- Sept
US: Biologics Part I, blood and blood products
- What are biologics?
- How are Blood and Blood products regulated? (http://www.fda.gov/ BiologicsBloodVaccines/ BloodBloodProducts/default.htm)
- Traceability and labeling
5 7-Oct US: Biologics Part II Vaccines; tissue and tissue products
Quiz 2
- What are other kinds of biologics?
- Regulation under 21 CFR 1270 versus 1271
- How are products regulated at CBER? - Biologics License Applications (BLA) Process - Premarket Approval (PMA) Process - New Drug Application (NDA) Process - 510(k) Process - Advertising & Labeling
(http://www.fda.gov/ BiologicsBloodVaccines/ ResourcesforYou/Industry/
default.htm)
- Biologic License Applications ( http://www.fda.gov/ BiologicsBloodVaccines/ DevelopmentApprovalProcess/ BiologicsLicenseApplicationsBLA Process/default.htm
- Vaccine BLAs (http:// www.fda.gov/ BiologicsBloodVaccines/ DevelopmentApprovalProcess/ BiologicsLicenseApplicationsBLA Process/ucm133096.htm)
6 14-
Oct
NO CLASS COLUMBUS DAY HOLIDAY
Oct
Introduction to QSR, GLP, GCP, and GMP
- QSR: QSR Video (1hr 45minutes – viewing is highly recommended)
- GLP: 21 CFR 58
- GCP ICH E6 (http://www.fda.gov/ downloads/Drugs/ GuidanceComplianceRegulatoryInf ormation/Guidances/ UCM073122.pdf)
- GMP: 21 CFR 210 and 211
8 28- Oct
US: Medical Devices Part I
Quiz 3
- What are devices?
- Device Submissions and content
- PMAs (http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarketYourDevice/ PremarketSubmissions/ PremarketApprovalPMA/ ucm050289.htm)
- 510(K)s http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarketYourDevice/ PremarketSubmissions/ PremarketNotification510k/ ucm142651.htm
- Device Labeling
(amended) (http://eur- lex.europa.eu/LexUriServ/ LexUriServ.do? uri=CONSLEG:1993L0042: 011:en:PDF)
12 25- Nov
EU Part II: Drugs and Biologics • What are drugs and biologics in the EU and how are they regulated?
- What is the European Medicines Agency
13 2-Dec Canada/Japan
Quiz 5
- Introduction to Health Canada ( http://www.hc-sc.gc.ca/index- eng.php )
- About Health Canada (http:// www.hc-sc.gc.ca/ahc-asc/index- eng.php)
- Discuss Therapeutics Products Directorate, Biologics and Genetic Therapies, Health Product & Food Branch Inspectorate
- Introduction to Japan’s PMDA ( http://www.pmda.go.jp/english/ index.html)
- Discuss Accreditation of Foreign Manufacturers, standards and test requirements
14 9-Dec Canada/Japan review continued (time permitting)
Student Presentations (8)
Canada/Japan review continued (time permitting)
NOTE: Attendance will count toward class Participation points
15 16- Dec
Student Presentations (8) Non-presenting student participation is also weighted for grade
NOTE: Attendance will count toward class Participation points
STUDENT PRESENTATIONS:
Option 1: Develop a Regulatory Strategy: Propose a registration strategy for a hypothetical biotechnology product. Students will propose a hypothetical product that a hypothetical company is developing. Making assumptions about testing available to them, students will develop a strategy for product registration and propose best practices for document preparation to accelerate regulatory approval. 15-minute presentation including Q&A from class.
Option 2: Design the framework for a regulatory submission: Based on a hypothetical product, students will provide a case study of either 1) submitting non-clinical data for support of an application for a clinical trial, 2) designing and submitting label and promotional materials based on hypothetically available testing, or 3) reviewing and submitting risk assessment documentation for a product dossier. 15-minute presentation including Q&A from class.
Option 3: Critique a Product Support: Using the internet, choose a (PMA or other) product of interest for which information is available on health agency websites. Retrieve publicly available information and comment on the associated testing. Provide a brief summary of what testing was conducted and what the studies showed were potential adverse effects. Discuss the strengths and weaknesses of the testing program as support for the regulatory requirements for market release. 15-minute presentation including Q&A from class.
Presentations will be evaluated on a scale of 1 to 100 with 1 being the least comprehensive and 100 being most comprehensive. Criteria for a successful proposal and presentation:
-Coherent outline for discussion
-Regulatory assessment demonstrating an understanding of the regulatory requirements for the product being discussed
-Anticipation and documentation of the questions that might be asked (and be prepared to answer them in your presentation)
-Reference to applicable standards or guidance documents
-Brief discussion of relevant regulatory agency, expected review/response timelines, application type(s)
-Citation of source research documents
