Title of Classes: Regulatory Issues in Biotechnology

Sponsor: UMBC

Dates: 9/3/2009 (Thursday) - 12/10/2009 (Thursday)

Time: 6:30-8:45pm (Thursdays)

Location: Frederick Community College

POC: UMBC Training Centers - (443) 543-5400

Audience: Open to ALL

Description: Overview: This course provides an in-depth study of the regulatory framework required to achieve approval of new products derived through biotechnology. The course will include class lectures and short research projects. Discussion of current reference articles and case studies will also be included. A final exam and project papers will be required for credit students. Lecture Topics: -Introduction to the Regulatory Approval Process; Overview of the FDA -Investigational New Drug Application (IND); Summary of regulations and guidelines -Introduction of cGMP's/principles of validation -Introduction to QA/QC principles -Good Laboratory Practice (GLP) compliance -Pre-clinical testing for biotechnology products; safety and toxicology -Clinical stages, design of clinical trials and protocols, evaluation of clinical data -Regulatory Filings: Biological License Application (BLA) -Pre-approval inspections -Team Biologics -International regulatory status for biotechnology products; WHO, Japan, and the EC/CPMP application -International Conference on Harmonization (ICH) update -Regulatory considerations for gene therapy and transgenic products Who should attend: Biotechnology,professionals/biochemicalengineers, Industrial and government researchers, Faculty and graduate students (engineering, chemistry, biology and pharmacy), Entrepreneurs, lawyers, patent attorneys with interests in biotechnology, Architects and engineers, Regulatory affairs professionals, Quality control/quality assurance professionals

Title of Classes: ACCT 410 Accounting for Government and Not-for-Profit Organizations (3)

Sponsor: University of Maryland University College (UMUC)

Dates: 9/8/2009 (Tuesday) - 12/15/2009 (Tuesday)

Time: 18:30-21:20 (Tuesdays)

Location: Fort Detrick Building 1520

POC: For more information on admission, registration or advising, please contact, Cindy Seiden at 301-738-6090 or cseiden@umuc.edu.

Audience: Open to EVERYONE (whether or not they are employed by the NCI-Frederick, DOD, DHS, NIAID, etc.).

Description: Prerequisite: ACCT 310. An introduction to the theory and practice of accounting and auditing as applied to governmental entities and not-for-profit organizations. Various techniques are used to study fund accounting concepts; these may include the use of problem sets, case studies, computer applications, and other materials. Students may receive credit for only one of the following courses: ACCT 410 or BMGT 410. For more information on UMUC, please visit their website at www.umuc.edu

Title of Classes: ACCT 411 Ethics and Professionalism In Accounting (3)

Sponsor: University of Maryland University College (UMUC)www.umuc.edu

Dates: 1/25/2010 (Monday) - 5/3/2010 (Monday)

Time: 18:30-21:45 (Mondays)

Location: Building 1520 (Fort Detrick's Training and Education Building)

POC: For more information on admission, registration or advising, please contact, Cindy Seiden at 301-738-6090 or cseiden@umuc.edu.

Audience: Open to EVERYONE (non-government and government).

Description: Prerequisite: ACCT 311. An analysis and discussion of issues relating to ethics and professionalism in accounting. The AICPA Code of Professional Conduct and the reasoning, philosophy, and application of that code are examined.

Title of Classes: BMGT 496 Business Ethics (3)

Sponsor: University of Maryland University College (UMUC) www.umuc.edu

Dates: 1/26/2010 (Tuesday) - 3/11/2010 (Thursday)

Time: 18:30-21:30 (Tuesdays and Thursdays)

Location: Building 1520 (Fort Detrick's Training and Education Building)

POC: For more information on admission, registration or advising, please contact, Cindy Seiden at 301-738-6090 or cseiden@umuc.edu.

Audience: Open to EVERYONE (non-government and government)

Description: A study of the relationship of business ethics and social responsibility in both domestic and global settings. Ethical and moral considerations of corporate conduct, social responsibilities, policies, and strategies are explored. Emphasis is on the definition, scope, application, and analysis of ethical values as they relate to issues of public consequence in the context of the functional areas of business at both the domestic and global levels.

Title of Classes: ACCT 422 Auditing Theory and Practice (3)

Sponsor: University of Maryland University College (UMUC) www.umuc.edu

Dates: 1/27/2010 (Wednesday) - 5/5/2010 (Wednesday)

Time: 18:30-21:30 (Wednesdays)

Location: Building 1520 (Fort Detrick's Training and Education Building)

POC: For more information on admission, registration or advising, please contact, Cindy Seiden at 301-738-6090 or cseiden@umuc.edu.

Audience: Open to EVERYONE (non-government and government)

Description: Prerequisite: ACCT 311. Recommended: ACCT 326. A study of the independent accountant's attest function. Topics include generally accepted auditing standards, tests of controls and substantive tests, and report forms and opinions. Various techniques are used to study auditing concepts and practices; these may include the use of problem sets, case studies, computer applications, and other materials. Students may receive credit for only one of the following courses: ACCT 422 or BMGT 422.

Title of Classes: FINC 330 Business Finance (3) *

Sponsor: University of Maryland University College (UMUC) www.umuc.edu

Dates: 1/27/2010 (Wednesday) - 5/5/2010 (Wednesday)

Time: 18:30-21:30 (Wednesdays)

Location: Building 1520 (Fort Detrick's Training and Education Building)

POC: For more information on admission, registration or advising, please contact, Cindy Seiden at 301-738-6090 or cseiden@umuc.edu.

Audience: Open to EVERYONE (non-government and government)

Description: Prerequisites: ACCT 221 and STAT 230. An overview of the theory, principles, and practices of financial management in a business environment. Topics include financial analysis and financial risk, characteristics and valuations of securities, capital investment analysis and decision making, the capital structure of the firm, financial leverage, and international finance. Emphasis is on the application of financial theory and methods for solving the problems of financial policy that managers face. Students may receive credit for only one of the following courses: BMGT 340, FINC 330, MGMT 398D, or TMGT 320 * Hybrid class which meets on-site approximately every other class session.

Title of Classes: IFSM 300 Information Systems in Organizations (3)

Sponsor: University of Maryland University College (UMUC) www.umuc.edu

Dates: 3/23/2010 (Tuesday) - 5/6/2010 (Thursday)

Time: 18:30 - 21:30 (Tuesdays and Thursdays)

Location: Building 1520 (Fort Detrick's Training and Education Building)

POC: For more information on admission, registration or advising, please contact, Cindy Seiden at 301-738-6090 or cseiden@umuc.edu.

Audience: Open to EVERYONE (non-government and government)

Description: (Course activities require access to Microsoft Office Professional.) Prerequisite: IFSM 201 and basic knowledge of office productivity software. An overview of information systems and how they provide value in organizations by supporting organizational (or business) objectives. Discussion covers human aspects of computing, types of computer systems, and general theory of systems and their relationship to the overall organization.

Title of Classes: Improving Spoken English

Sponsor: NIH Office of Intramural Training and Education

Dates: 12/1/2009 (Tuesday) - 12/1/2009 (Tuesday)

Time: 1:00-3:00pm

Location: Building 549/Auditorium

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: Designed for scientists whose first language is not English, this seminar offers helpful hints on improving spoken English. It covers diction, voice production, tempo, the pronunciation of scientific words, and general hints for communicating successfully with individuals and groups in the U.S.. After the seminar, participants will be given the opportunity to register for practice in small groups. Speaker: Scott Morgan, MA, Premiere Public Speaking

Title of Classes: Scientists Teaching Science

Sponsor: NIH Office of Intramural Training and Education

Dates: 1/25/2010 (Monday) - 1/25/2010 (Monday)

Time: 1:00-3:00pm

Location: Building 549/Auditorium

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: Speaker: Barbara Houtz, a nationally-recognized teacher with over 13 years' experience in training teachers. Are you interested in learning the basics of successful teaching? Are you thinking about a career in education? If you answered “yes” to either of these questions consider signing up for the OITE workshop, "Scientists Teaching Science: An Introduction to Best Practices in Science Education." The workshop will provide an introduction to learning styles, teaching philosophies, and course development for graduate students and postdoctoral fellows. This workshop is a prerequisite for admission to the in-depth pedagogy course the OITE will offer in the spring.

Title of Classes: Assertiveness: How to Ask for What You Need in the Lab and in Life

Sponsor: NIH Office of Intramural Training and Education

Dates: 2/9/2010 (Tuesday) - 2/9/2010 (Tuesday)

Time: 11:00am-2:00pm

Location: Building 426/Conference Room

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: Speaker: Anne Kirchgessner, Career Counselor, OITE. · Do you have a suggestion for improving efficiency in your lab but lack the confidence to bring it to the attention of your PI? ·Do you need additional resources for your experiments or time off for an important family activity but don't know how to ask? ·Are you afraid to mention the fact that you are having major difficulty dealing with one of your lab mates? Join an experienced career counselor from the OITE Career Services Center to explore strategies for communicating your needs in a variety of situations. Learn how to be more assertive, to speak up for yourself, and how to decide when to speak up and when not to. Limited to 20 participants.

Title of Classes: Working and Playing Well with Others: Using the Myers-Briggs Type Indicator to Understand Yourself and Those around You

Sponsor: NIH Office of Intramural Training and Education

Dates: 3/24/2010 (Wednesday) - 3/24/2010 (Wednesday)

Time: 11:00am - 2:00pm

Location: Building 549/Auditorium

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: The Myers-Briggs Type Indicator (MBTI) is the most widely used personality assessment in the world for understanding individual differences and uncovering new ways to work and interact with others. Once we understand how we relate to others, ourselves, and the world around us, we can learn how to work with others who view the world through a different lens. This three-hour session uses the MBTI to help participants understand their own and others' styles in order to enhance individual and team performance at work, develop leadership skills, and reduce workplace conflict through improved interactions.

Title of Classes: Goal Setting

Sponsor: NIH Office of Intramural Training and Education

Dates: 4/29/2010 (Thursday) - 4/29/2010 (Thursday)

Time: 9:30-11:00am

Location: Building 549/Auditorium

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: Speaker: Lori Conlan, PhD, OITE Office of Postdoctoral Services Learn how to establish personal, professional, and career goals with consideration for your current career status, previous experiences, and future aspirations. Topics include work and life balance, short-term vs. long-term goals, and Individual Development Plans (IDPs).

Title of Classes: Interacting with People from the U.S.

Sponsor: NIH Office of Intramural Training and Education

Dates: 5/11/2010 (Tuesday) - 5/11/2010 (Tuesday)

Time: 11:00am-2:00pm

Location: Building 549/Auditorium

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: Speaker: Julie Gold, Leadership and Professional Development Coach, OITE Are you trying to understand how U.S. friends, colleagues, and interviewers expect you to behave? This seminar will offer tips on interacting with people from the U.S. in common work and social situations. There will be an opportunity for open discussion as well, so bring your specific questions about things in U.S. culture that you’ve found confusing or strange.

Title of Classes: Basic Science Writing

Sponsor: NIH Office of Intramural Training and Education

Dates: 6/4/2010 (Friday) - 6/25/2010 (Friday)

Time: 10:00am - 1:00pm (Thursdays)

Location: Building 426/Conference Room

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: Speaker: Marguerite Meitzler June 4, 11, 18, 25 All scientists know the importance of developing great writing skills. This 4-week course is for any trainee interested in improving his/her writing skills. Designed to be helpful to both native and non-native English speakers, this examples-based course will focus on topics such as grammar and sentence structure, punctuation, writing coherent sentences and paragraphs, and reworking for clarity and brevity. Each session of the class is limited to 35 participants. In addition to in-class writing practice using short exercises, students will be members of in-class review groups giving feedback to their colleagues. The instructor will provide individual in-class writing guidance and review and analyze weekly writing assignments, providing written feedback. Students interested in taking this class must commit to 8 to 10 hours per week to writing/editing outside of the classroom. Attendance and active participation at all 4 course sessions is required. All participants must purchase a copy of CliffsQuickReview Writing: Grammar, Usage, and Style by Jean Eggenschwiler and Emily Dodson Biggs, Wiley Publishing. The cost of this book is about $10.

Title of Classes: Writing and Publishing a Scientific Paper

Sponsor: NIH Office of Intramural Training and Education

Dates: 6/4/2010 (Friday) - 6/25/2010 (Friday)

Time: 2:00-5:00pm (Thursdays)

Location: Building 426/Conference Room

POC: Julie Hartman: hartmanjb@mail.nih.gov

Audience: Everyone

Description: Speaker: Marguerite Meitzler June 4, 11, 18, 25 This 4-week course is for postdocs and graduate students who, by the start of the class, will have sufficient data to publish a scientific paper. Course sessions focus on writing abstracts, discussions, and other manuscript sections, construction of figures and tables, and understanding the publication process. Each session of the class is limited to 35 participants. Students will be members of in-class review groups giving feedback to their colleagues. The instructor will provide individual in-class writing guidance. She will also review weekly writing assignments and provide written feedback. Students interested in taking this class must commit to 8-10 hours per week to writing/editing outside of the classroom. Attendance and active participation at all 4 course sessions is required. All participants must purchase a copy of Successful Scientific Writing: A Step-by-Step Guide for the Biological and Medical Sciences by Janice Matthews and Robert Matthews, Cambridge University Press (2007). The list price of this book is $34.99.

Title of Classes: Effective Writing Series: Editing and Proofreading - Doing a Double-Take

Dates: 12/10/2009 (Thursday) - 12/10/2009 (Thursday)

Time: 12:00p.m. - 1:00 p.m.

Location: Training Room, Bldg 426

POC: Sukanya Bora

Audience: Open to all Government and Contractor employees at NCI-Frederick

Description: What’s the best way to start your sentences? How can you cut that letter down to one page? Are Spell Check and Grammar Check really useful? Get tips on how to edit and proofread so that you write with better clarity and brevity. Facilitators: Scientific Publications, Graphics & Media (SPGM) staff

Title of Classes: Coping with the Holidays: How to manage Stress during Festive Season

Dates: 12/2/2009 (Wednesday) - 12/2/2009 (Wednesday)

Time: 12:00 p.m.- 1:00 p.m.

Location: Conference Room A, Bldg 549

POC: Sukanya Bora

Audience: Open to all Government and Contractor employees at NCI-Frederick

Description: Despite the excite and energy that comes with the end of the calendar year, the holiday season often brings stress to many of us, for a variety of reasons. Whether through unreasonable expectations, unmet goals from years past or simply adding to already busy schedules, holidays can generate pressure, tension and stress for both individuals and families. This session assists participants in recognizing sources of holiday stress and tension. Once recognized, these stresses can be minimized through development of strategies to promote joyful holiday season.

Title of Classes: Principles of Clinical Pharmacology

Dates: 9/3/2009 (Thursday) - 4/22/2010 (Thursday)

Time: 6:30pm-7:45pm (Thursdays)

Location: Building 549, Scientific Library's Technology Training Lab

POC: Marci Brandenburg, brandenburgm@mail.nih.gov

Audience: Open to EVERYONE (whether or not they are employed by the NCI-Frederick, DOD, DHS, NIAID, etc.).

Description:  The program covers much of what researchers need to know about the clinical pharmacologic aspects of drug development and use, including pharmacokinetics, drug metabolism and transport, assessment of drug effects, drug therapy in special populations, and drug discovery and development. Certificates of participation will be awarded at the end of the course to all students who attend at least 75 percent of the lectures. For more information, go to http://www-library.ncifcrf.gov/nihcourses.aspx#pcp.

Title of Classes: Introduction to the Principles and Practice of Clinical Research

Dates: 10/19/2009 (Monday) - 3/9/2010 (Tuesday)

Time: 5:00pm-6:30pm (Mondays and Tuesdays)

Location: Building 549, Scientific Library's Technology Training Lab

POC: Marci Brandenburg, brandenburgm@mail.nih.gov

Audience: Open to EVERYONE (whether or not they are employed by the NCI-Frederick, DOD, DHS, NIAID, etc.).

Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains researchers in how to design a successful clinical trial by focusing on epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance and FDA issues. Other areas covered include data management and ethical issues, including protection of human subjects. For more information, go to http://www-library.ncifcrf.gov/nihcourses.aspx#ippcr.

Title of Classes: More to Google than a Quick Search

Dates: 12/1/2009 (Tuesday) - 12/1/2009 (Tuesday)

Time: 10:00am-11:30am

Location: Building 549, Scientific Library's Technology Training Lab

POC: Marci Brandenburg, brandenburgm@mail.nih.gov

Audience: Open to all Government and Contractor employees at NCI-Frederick

Description: This class is designed to explore Google services beyond the basic search. It goes over constructing more complicated and advanced searches in Google, in addition to the use of Google as a reference tool (ex. Calculator). It also discusses Google Scholar, Google Book Search, Google Reader, and more. See http://www-library.ncifcrf.gov/libclass.aspx for additional information on training classes offered by the Scientific Library.

Title of Classes: Finding Health Information Online

Dates: 12/10/2009 (Thursday) - 12/10/2009 (Thursday)

Time: 10:00am-11:30am

Location: Building 549, Scientific Library's Technology Training Lab

POC: Marci Brandenburg, brandenburgm@mail.nih.gov

Audience: Open to all Government and Contractor employees at NCI-Frederick

Description: Have you ever needed health information written with patients or the parents of patients in mind? This class will explore finding and evaluating web health-related web sites, as well as introducing the resources available at the Scientific Library's Center for Health Information.