This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM

In a blending of online and live learning, this course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system and central nervous system. Inflammation and anti-inflammatory drugs are next presented and the course concludes with a discussion of agents used in infectious disease and chemotherapy. The online component is PERI¿s Pharmacology Online Course. PERI strongly recommends that participants complete the online component before attending the live course as concepts covered in the online component will be built upon in the live portion. To review the online course Pharmacology Online, click here. Please note: You do not need to register for both the live AND online components. Upon registering for the Basic Pharmacology Training Course, you will automatically receive access instructions to the online course in your Confirmation Letter.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM

Step back in time with Medical Devices: An Introduction to review the progress made to ensure the safety of medical devices. This courser will also identify critical definitions, classifications and device categories. What constitutes a medical device and how are they different from drugs? What role does the Food and Drug Administration play in the regulation of medical devices? How are devices classified in the US and the EU? These are just a few of the questions that will be addressed

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM

In a blending of online and live learning, this course will provide an overview of the process and issues common to all new chemical entity (NCE) development projects. The course will focus on the decisions that need to be made throughout the drug development process and the criteria influencing these decisions. The faculty for this Gold Standard course are selected as experts in their field. The online component is PERI¿s Decision Points Course. PERI strongly recommends that participants complete the online component before attending the live course as concepts covered in the online component will be built upon in the live portion. To review the online course Decision Points, click here. Please note: You do not need to register for both the live AND online components. Upon registering for Pharmaceutical Development: From Molecule to Market, you will automatically receive access instructions to the online course in your Confirmation Letter.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM

This course will provide a comprehensive overview of asthma and COPD as a basis for developing new drugs to more effectively treat these diseases. A background on basic pulmonary physiology, standard approaches to pulmonary physiologic testing, current treatment approaches, and aerosol administration techniques will be provided. In addition, a review of regulatory policies in this area will be used to discuss recent approaches to developing new drugs for asthma and COPD.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:30 PM
Day 2: 8:00 AM - 5:00 PM

This course will provide a comprehensive overview of US/FDA, European, Canadian, Japanese and Rest-of-World (ROW)/emerging market regulations for drugs and biologics development from pre-clinical to post approval. Emphasis will be on FDA, European, and Canadian regulatory similarities and differences. Interactive sessions and workshops will identify and address regulatory obstacles faced by regulatory affairs professionals.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:45 PM
Day 2: 8:00 AM - 4:00 PM

This course provides a detailed review of the legal and regulatory principles driving prescription drug labeling, and patient labeling in the United States, Canada and the European Union. It addresses postmarketing communication to consumers and healthcare professionals, as well as providing an overview of product liability and public health policy issues in the United States. Also covered will be the clinical content structuring and coding based on the SPL Clinical Information Model ¿SPL 2b¿ and its implications on writing labels.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM

This course provides an overview of the clinical trial process with particular emphasis on planning and management. A balanced presentation of process and opportunity for detailed discussion and networking will address specific situations that impact efficiency, cost, and study completion. Interactive sessions serve as the basis for thoughtful analysis of how to design effective and efficient studies.

Day 1: 8:00 AM - 5:30 PM
Day 2: 8:00 AM - 5:00 PM
Day 3: 8:00 AM - 5:00 PM

This course will provide an overview of human cancer with discussions of specific cancer types, clinical and epidemiologic features, current therapeutics, and design and conduct of Phase I, II & III clinical trials. The US Food & Drug Administration (FDA) regulatory requirements for clinical trial designs and drug development programs are also covered.

Day 1: 8:00 AM - 5:30 PM
Day 2: 8:00 AM - 5:30 PM
Day 3: 8:00 AM - 12:30 PM

This course focuses on regulatory requirements that impact the management and handling of drug safety data and adverse event reporting. Significant regulatory changes from the sponsor's and FDA's view will be reviewed, including current FDA regulations and Guidances and how they will be implemented. This course will also provide an opportunity for those working in safety surveillance to gain an in-depth understanding how these regulations relate to international activities in CIOMS and ICH. This course will be highly interactive, with participants partaking in small group discussions and case studies emphasizing expedited and periodic reporting, decision-making and crisis management.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:30 PM
Day 2: 8:00 AM - 5:30 PM
Day 3: 8:00 AM - 4:30 PM

This course addresses the global aspects of drug development. In this highly interactive course participants will gain a better understanding of the overall drug development and regulatory processes by participating in a simulated drug development and review process. Participants will form a "company project team" working together to get their "drug" approved with the required label and within projected timeline and budget. The initial portion of the course provides didactic presentations, which include lectures on drug development strategy, IND/NDA regulations, non-clinical safety and development, chemistry, manufacturing and controls (CMC), and clinical pharmacology and clinical development. These presentations by real-world functional area experts provide the groundwork for the IND and NDA Game simulations.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:50 PM
Day 2: 8:00 AM - 5:30 PM
Day 3: 8:00 AM - 12:15 PM

This course provides an intuitive approach to pharmacokinetic (PK) concepts, using easily understood mathematical and descriptive teaching methods. Emphasis will be on Absorption, Distribution, Metabolism and Elimination (ADME) principles, bioavailability/bioequivalence issues, non-linearity in pharmacokinetics, and concepts related to Pharmacokinetic/Pharmacodynamic relationships. All of the concepts are brought together in a hands-on workshop designed to interpret a real-life drug development scenario. This course allows you to interact with the faculty in small group workshops and special interest sessions. There will be ample time for question and answer sessions with the faculty. Please bring a scientific calculator with you to the course for hands-on pharmacokinetic parameter estimation.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM

This course provides a basic overview of fundamental statistical principles. The course is intended for those who have not comprehensively studied statistics, but would like to gain an understanding of the basic notions that underlie statistical thinking through real-world examples. A series of workshop sessions will be interwoven with lectures and discussions. This course is not a substitute for a formal course instatistical methods, but rather will serve to introduce general statistical concepts, and form a foundation for reading and interpreting statistical materials and terms (such as P-Value, hypothesis testing, confidence intervals, power, sample size, and variability). At the conclusion of the course, participants will be able to effectively communicate with statisticians and better understand statistical material in reports and journals.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM
Day 3: 8:00 AM - 4:00 PM

The course is designed to cover oncologic clinical trials from Phase I through Phase III with discussions of relevant design, ethical and regulatory issues, as well as results of complex trials for both cytotoxic and non-cytotoxic agents. Lecturers will be clinical research oncologists and clinical pharmacologists with experience in oncologic clinical trials either at the pharmaceutical sponsor or clinical research level. This course will provide insight into the application of biomarkers to oncology clinical trial development with particular emphasis on the use of circulating biomarkers in serum/plasma/urine and whole blood as surrogate endpoints

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM
Day 3: 8:00 AM - 5:00 PM

This course provides a brief history of biologics and how they are regulated, describes the key aspects of chemistry, manufacturing and controls (CMC) for various types of biologic products, defines principles underlying biologics safety and clinical trial assessments, and aids in developing a planning strategy for toxicology and clinical studies supporting biological drug development. Participants will gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM

This two-part course provides physicians, nurses and scientists with a focus on discovery to the start of Phase II of the drug development process. The course addresses the functions and critical decisions made throughout Phases I and II in submitting an IND application and clinical trial design protocol. Attendance at Part I before Part II is encouraged, but not essential.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM

This course will provide an introduction to the cancer disease process and an overview of treatment method categories. Also discussed will be: adverse effects of treatments and design of oncology clinical trials, and the approval process of oncology drugs. Several specific cancer types (lung, breast, colorectal, ovarian, pancreatic, and others) will be discussed.

This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209

Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 4:30 PM

FDA FACULTY CONFIRMED

This course will provide an overview of key issues in the development of pediatric drug development. Experts from the industry, FDA and academia will address issues including but not limited to pediatric vs. adult clinical trials; regulatory considerations; ethics; design of pediatric clinical trials, statistical consideration in trial design, and patient recruitment and retention.