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31st Annual Seminar by the Sea Northeast Regional Conference "Breaking Boundaries: New Opportunities for Pharmacists "

Breaking Boundaries: New Opportunities for Pharmacists 31st Annual Seminar by the Sea Northeast Regional Continuing Education Conference for Pharmacists Pre-Conference Workshop, Wednesday, March 30, 2016 Compounding: Implementing Best Practices for USP and USP Plenary Sessions, 2-Day Agenda, March 31 & April 1, 2016 Thursday, March 31, 2016 7:00 AM Registration, Breakfast and Exhibitors, Grand Ballroom Foyer and Brenton Hall 8:00 AM Welcome, Program Overview and Campbell...
University of Rhode Island College of Pharmacy

Essentials of Non-Sterile Compounding

The practice of compounding pharmacy has undergone a significant evolution in requirements and practices in just the past year, and predictions suggest change will continue for some time to come. It is imperative that we evolve our historically reactive behaviors to a more prospective behavior that will anticipate change far before a response is necessary. This one hour webinar will provide specific considerations that non-sterile compounding pharmacy personnel can utilize to protect their bus...
International Academy of Compounding Pharmacists (IACP)

Growing Your Pharmacy Business Through Sales and Marketing While Avoiding Regulatory Scrutiny

Substantially review the provisions and details of Federal and State laws/regulations. Visually display risks of different courses of conduct through multimedia relating to pharmacy marketing. Analyze effects through common scenarios and case studies. Provide pointers and tips on how to bring pharmacy practice to compliance. At the conclusion of this program, the pharmacist and technician attendee will be able to: • Discuss different methods of employing a sales force and marketing c...
International Academy of Compounding Pharmacists (IACP)

MIA: Medication Issues of Adherence

Medication adherence is considered an epidemic according to the World Health Organization. It is important that pharamcists help patients find effective ways for patients to adhere to treatment plans. In this activity, pharmacists will analyze how to work with patients to achieve adherence to medications, factors and barriers to non-adherence, and add value and goals to a patient's treatment to allow for better patient outcomes. Tools will be provided that the learner will be able to use and a...
MCPHS University

Massachusetts Prescription Monitoring Program (PMP): An Overview

The Massachusetts Prescription Monitoring Program (MA PMP) is a tool that supports safe prescribing and dispensing and assists in addressing prescription drug misuse, abuse and diversion. The MA PMP collects dispensing information on prescription drug products with recognized potential for abuse or dependence (e.g., narcotics, stimulants, sedatives). The Drug Control Program (DCP) analyzes the PMP data to determine prescribing and dispensing trends; provide patient prescription history informa...
MCPHS University

Practicing Evidence Based Medicine: From IRB Approval to Bench Research

This one-hour webinar is presented by two IACP Foundation academic research investigators to bring attendees education on the Foundation’s research initiatives to advance the practice of pharmacy compounding. In the first half of this webinar, participants will learn about the Institutional Review Board (IRB) submission process, identify common barriers and pitfalls that can occur, and examine methods for overcoming these barriers using case vignettes. In the second half, attendees will anal...
International Academy of Compounding Pharmacists (IACP)

Building a Compounding Practice: Lessons Learned

This one hour webinar is geared towards attendees who are assessing compounding pharmacy ownership. By outlining best practices and potential pitfalls, attendees will have the necessary background information to create essential Standard Operating Procedures (SOPs), a well-rounded working environment, and a functional pharmacy design. At the conclusion of this program, the pharmacist and technician attendee will be able to: • Outline Standard Operating Procedures (SOPs) for the pharm...
International Academy of Compounding Pharmacists (IACP)

“Constructive Delivery” Under the Controlled Substances Act

This session will give attendees the knowledge necessary to make informed decisions about appropriate registration under the Controlled Substances Act (CSA) and how to maintain compliance with the CSA. At the conclusion of this program, the pharmacist and technician attendee will be able to: • Identify the current Drug Enforcement Administration (DEA) interpretation of the definitions in the Controlled Substances Act (CSA). • Explain the “Manufacturer” registration process und...
International Academy of Compounding Pharmacists (IACP)

Endotoxin Testing and Environmental Monitoring for Your Pharmacy

As the demand for compounded medications has increased and in light of recent tragic events, the pharmaceutical sterile compounding profession requires a greater understanding of quality assurance testing. This presentation will educate individuals about sterile compounding principles of bacterial endotoxin testing and environmental monitoring. Attendees will gain technological knowledge about how to implement the highest quality compound preparations for their patients. At the conclusion ...
International Academy of Compounding Pharmacists (IACP)

Setting Strategies – Short and Long Term

How blue is your ocean? By default, compounding is a Blue Ocean. Through patient care, pharmacists before us created new demand in an uncontested market space (Blue Ocean) rather than by competing head-to-head with other suppliers for known customers in an existing industry. But now that compounding has become more common place … have we forgot about the blue ocean? In this hour you’ll learn how to continue your long term goals of growing your business while making slight course correction...
International Academy of Compounding Pharmacists (IACP)

Sales Calls - Preparation and Execution

On average a physician’s office may be visited by 10 sales reps a day. Not just drug reps, but vitamin sales, skin care sales, equipment sales. Now why do they want to listen to what you have to say? The sales call doesn’t start once you open the car door. The sales process starts with identifying the client, understanding their needs, knowing your product and finally matching up those needs. At the conclusion of this program, the pharmacist and technician attendee will be able to: ...
International Academy of Compounding Pharmacists (IACP)

The One Page Marketing Plan

You know you need your marketing plan. We’re not going to debate the merits. What you don’t need is a 100 page marketing plan. One page will suffice. Learn how to drill down to the who, what, where, why & when to maximize your efforts and keep your staff on the same page - the one page marketing plan. At the conclusion of this program, the pharmacist and technician attendee will be able to: • Identify the who, what and why of their market. • Describe metrics and what to look f...
International Academy of Compounding Pharmacists (IACP)

Ask The Marketer

Excellent marketers are a rare breed. They make cold calls, visit doctors, navigate the maze of gate keepers and yet manage to smile through it all. Want to know how they do it? In this session you’ll be able to do just that. At the conclusion of this program, the pharmacist and technician attendee will be able to: • Identify new opportunities with their current customers. • Discuss the benefits of hiring a marketer for their pharmacy. • Demonstrate opportunities to reward ma...
International Academy of Compounding Pharmacists (IACP)

What’s Going on Legislatively & Judicially? A Pharmacy Law Update

Most pharmacists rely on their professional associations or their Board of Pharmacy to keep them informed and up-to-date about changes in practice acts at the federal and state levels. But did you know that the judicial branch – the court system – also affects pharmacy law? Over the past year, there have been some interesting legal challenges pertaining to pharmacy and pharmaceuticals which directly affect your daily practice. This session will provide an easy-to-understand overview of the...
International Academy of Compounding Pharmacists (IACP)

FDA & Marketing of Compounds

What legal considerations impact drug advertising? How are they evolving? How have they been impacted by social media? This session will explore the basic legal and policy issues associated with the promotion of prescription drugs in the United States and discuss their application to compounded medicines. At the conclusion of this program, the pharmacist and technician attendee will be able to: • Discuss legal and policy issues associated with the promotion of prescription drugs. ...
International Academy of Compounding Pharmacists (IACP)

Public and Political Perception of Compounding

Sometimes it’s not what you say, it’s how other people hear. That’s never more true when it comes to the public’s perception of compounding pharmacy over the past few months. Where most consumers and even most politicians knew little to nothing about compounders, now the impression is that they are “dangerous.” IACP’s Washington D.C. legislative and public relations team will review the hard-learned lessons of “do’s and don’ts” of advocacy, how to tackle misperceptions he...
International Academy of Compounding Pharmacists (IACP)

Pharmacy Compounding Law and Regulations: Staying Current in a Changing World

This one hour webinar is an in-depth presentation on federal and state legislative and regulatory issues that are affecting compounders today. Attendees will learn how regulatory initiatives and court decisions have influenced the regulation of compounders, the authority of the Food and Drug Administration (FDA) when inspecting compounding pharmacies, and up-to-date information on the current federal proposed legislation. Are YOU current on your compounding pharmacy law? Never assume. This is ...
International Academy of Compounding Pharmacists (IACP)

Working with a Patient Safety Organization: Improve Quality and Reduce Legal Risk

The Patient Safety and Quality Improvement Act of 2005 (PSQIA or the Act) was passed to create a culture of safety in the practice of medicine, including in pharmacy practice. The Act provides an event reporting shield for medication dispensing errors to remove fear of legal liability, professional sanctions, and injury to professional reputation that prevents pharmacists from sharing information that can improve quality. The Patient Safety Organization (PSO) framework provides an opportunity ...
International Academy of Compounding Pharmacists (IACP)

Media Relations for Your Pharmacy

You are busy serving your patients and running a pharmacy, so why do you need to worry about the media and public relations? While this is a perception that is held by many, the media can have a dramatic impact on the way patients and the public perceive your pharmacy. Working with the local media can result in a positive news story about your pharmacy and its specialized services. Not working with the media, on the other hand, can have a very damaging effect upon that perception, particularly...
International Academy of Compounding Pharmacists (IACP)

School Administrator Training (on CORE ELMS / RXpreceptor software) for Internship, Externship, and Experiential Education Departments of Participating Colleges and Universities

In depth, hands on training of all aspects and modules found within the RXpreceptor ELMS (Experiential Learning Management System) software. After completion of this training, school administrator will be able to fully set up and utilize the school’s RXpreceptor account, as well as train students and preceptors on account utilization. Covered topics include: * **Initial Account Setup** * System Configuration * System Flags and Options * Program Customization * Branding Incorporati...
CORE ELMS - Experiential Learning Management System (ELMS)

URI College of Pharmacy Mobile App Download

From CE & Snow in ski country to Seminar by the Sea in Newport to the June Minicourse Series and everything in between, there is always something happening at URI. Use this app to stay up to date! Download the FREE mobile app onto your mobile device by visiting www.careertapp.com
CareerTapp

Asthma, Calming the Airway

Clinical characteristics of asthma and related airway inflammation, plus the host and environmental factors that contribute to asthma, as well as medication management and the client education essential to optimal results. When you finish this course, you will be able to: *Discuss the incidence and prevalence of asthma in the United States. *Explain the assessment and diagnosis of asthma. *Summarize the differential diagnosis and comorbidities of asthma. *List the environmental factor...
ATrain Education Inc.

Alzheimer's Disease and Related Dementias, 6 units

Provides healthcare workers with the skills, techniques, and strategies to care for those who have Alzheimer’s disease or a related dementia. It includes activities that allow participants to practice the skills and strategies they have learned. When you finish this course, you will be able to: *Describe three differences between Alzheimer’s dementia and non-Alzheimer’s dementia. *State the three National Institute on Aging and the Alzheimer's Association stages of dementia. *Ide...
ATrain Education Inc.

Coronary Artery Disease (CAD)

Traces the gradual development of the atherosclerosis that underlies CAD and includes causes, risk factors, diagnosis, management, and complications. Concludes with the components of a cardiac rehabilitation program.
ATrain Education Inc.

Balance, Postural, and Falls in Older Adults

Discussion of the scope, morbidity, and mortality related to falls and fall risk in older adults. Strategies for assessing and preventing falls in older adults, with discussion of age-related risk factors including polypharmacy. Description of common screening and assessment tools used to identify fall risk in older adults and suggested interventions are designed to improve balance and reduce the risk of falls. When you finish this course, you will be able to: *Provide definitions for b...
ATrain Education Inc.

Acetaminophen: When It Becomes Dangerous

Acetaminophen use and overuse with focus on signs and symptoms of liver injury, including FDA-recommended potencies for various age cohorts and at-risk populations. When you finish this course, you will be able to: *Explain the widespread use of acetaminophen both as an over-the-counter drug and by prescription in combination with other drugs. *Discuss self-dosing of acetaminophen as an OTC drug and the hazard of unintentional overdose. *Describe the relationship of acetaminophen to ac...
ATrain Education Inc.

Granulation, Tableting and Capsule Technology

This two-day course will focus on the technologies used in pharmaceutical granulation compression and encapsulation including powder blending, dry and wet granulation, drying, compression and encapsulation. The course will focus particularly on the control technologies and how they interact with each other and on the product. It will be of benefit to scientists and technologists working in product development, manufacturing, production support, quality control and regulatory affairs. This i...
The Center for Professional Innovation and Education

Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

This course provides a comprehensive description of the various regulatory and legal standards and their specific application to the advertising and promotion of drug and medical device products including detailed analysis of advertisements and promotion. These include regulations and policies of the FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), state attorneys general and prosecutors, and professional guidelines of relevant organizations including ACCME, ACP, PhRMA and the AMA. ...
The Center for Professional Innovation and Education

Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

This course provides a comprehensive description of the various regulatory and legal standards and their specific application to the advertising and promotion of drug and medical device products including detailed analysis of advertisements and promotion. These include regulations and policies of the FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), state attorneys general and prosecutors, and professional guidelines of relevant organizations including ACCME, ACP, PhRMA and the AMA. ...
The Center for Professional Innovation and Education

The Drug Development Process - From Discovery to Commercialization

The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies. Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the deve...
The Center for Professional Innovation and Education

Global Review of Sunscreen Science, Products & Regulation

To formulate a successful sunscreen product for topical application requires a multidisciplinary approach. Factors need to be taken into consideration include the current market trends & demands, regulatory framework & compliance requirements, scientific learning on skin structure and function, UV-interacting chemistry & science, and appropriate delivery systems for optimal effectiveness and safety. This course will provide an overview of sunscreen regulations and technologies that enable the ...
The Center for Professional Innovation and Education

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites. Additionally, attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover miscondu...
The Center for Professional Innovation and Education

FDA Inspections -What Regulators Expect and How to Prepare

This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities. Additional benefits of this class include discussion of: •FDA authority and process including 483s, Warning Letters, recalls, and other potential actions •The FDA inspection process and approach •Device Master Records requirements ...
The Center for Professional Innovation and Education

Preparing the CMC Section for NDAs-CTDs-INDs

This course includes an overview of the International Conference on Harmonization (ICH) process and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of NDAs and INDs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, and pharmaceutical development reports. It will also discuss the use of D...
The Center for Professional Innovation and Education

Lyophilization Technology - Practical Application of the Scientific Principles

This course is designed to provide attendees with a practical approach to understanding the scientific and engineering principles of lyophilization. The topics discussed during the course will be presented to explain the physical, physicochemical, biochemical, and engineering principles of the science and engineering behind modern freeze-drying. The practicality of the course allows the attendees to get a firm understanding of the theoretical applications of freeze-drying and how these can be ...
The Center for Professional Innovation and Education

Auditing and Qualifying Suppliers and Vendors

Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the company’s responsibility to ensure their suppliers/vendors meet all regulatory specifications for the supplied materials, components, equipment and/or services. For many years, industry has implemented procedures for selection, approval and qualification of supplier...
The Center for Professional Innovation and Education

Global Personal Care Market and Regulatory Overview

Cosmetic products are ubiquitous in our daily life. Consumers are bombarded with newer and more attractive product offerings constantly. The cosmetic and toiletry industry continues to enjoy relatively good standing despite global recession. While traditional stronghold such as Western Europe, Japan, and the US appear to have been near their market saturation, the emerging markets such as Latin America and Asia have been roaring ahead with powerful growth. The former usually have established f...
The Center for Professional Innovation and Education

Medical Devices – EU Directives Guidance CE Marking and ISO Standard Certifications

The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make it a straightforward process to get products approved in each country - but is it? This course works through the requirements for medical devices, the steps to obtain entry into the marketplace (including setting up a number of on-going procedures and relationships), and shares some lessons learned from the Course Director, w...
The Center for Professional Innovation and Education

Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries

If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don’t tell you how. Based on industry best practices, this course clarifies ...
The Center for Professional Innovation and Education

Integration of Risk Management Principles and Activities into the Quality System

The market’s Tolerance for Failure of Drugs, Devices and IVDs has reduced significantly since the 80s. This reduced tolerance is a reflection of a general loss of confidence in the medical industry. Adoption and certification of Quality Management Systems (QMS) has provided some recovery of that lost confidence but not enough – more is needed New requirements combined with concepts and applications of Risk Management as a practical set of principles, have emerged and when integrated with...
The Center for Professional Innovation and Education

Writing Effective Standard Operating Procedures and Other Process Documents

This course presents a comprehensive overview of process writing that the binding regulations require. There’s a tenet among regulatory bodies: "If you didn’t write it down, it didn’t happen," and while the regulations tell companies what they need to do and document, they don’t tell them how. Determining how systems work and how processes occur and documenting them is up to companies to assess. This course presents process writing within the "big picture" of controlled documentation a...
The Center for Professional Innovation and Education

Introduction to Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries

Molecular biology pertains to the study of living systems at the DNA, RNA, and protein levels, and how these molecules can be modified and harnessed for practical applications. Knowledge of the natural function of these molecules in the cell provides a context appropriate for further advancement in the rapidly expanding areas of functional genomics, cell biology, biotechnology, microbiology, diagnostics, therapeutics, and personalized medicine. This course, intended for the non-specialist...
The Center for Professional Innovation and Education

Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries

Course notes and interactive exercises address how to write effective correspondence and reports in support of the company’s activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others’ writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address sp...
The Center for Professional Innovation and Education

Safety Assessment of Cosmetic Ingredients and Formulations

This two-day comprehensive course is aimed at providing the spectrum of reasons, rationale, tools and approaches to test the safety of ingredients, formulations and skin devices in the topical pharmaceutical, cosmetic, personal care and skin medical device industries. In the current environment of establishing regulations and environmental issues awareness, this course was created in order to offer guidance to professionals in the industry who are concerned with present approaches and futur...
The Center for Professional Innovation and Education

Introduction to Effective Medical Writing

Medical writing is both a science and an art. The art of medical writing is to comprehend and present scientific information clearly to suit the specific target audience’s level of understanding including patients, the general public, physicians and/or regulatory agencies. Often it is not poor science that kills a scientific paper; rather, it is the lack of clarity and continuity. Poor writing can be very costly to companies and frequently slows the review process of regulatory submission...
The Center for Professional Innovation and Education

The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation

The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe. The eCTD format has become mandatory in key markets for electronic submissions. Since January 2010, the European Medicines Agency has required ...
The Center for Professional Innovation and Education

Writing Effective Standard Operating Procedures and Other Process Documents

This course presents a comprehensive overview of process writing that the binding regulations require. There’s a tenet among regulatory bodies: "If you didn’t write it down, it didn’t happen," and while the regulations tell companies what they need to do and document, they don’t tell them how. Determining how systems work and how processes occur and documenting them is up to companies to assess. This course presents process writing within the "big picture" of controlled documentation a...
The Center for Professional Innovation and Education

Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries

If you didn’t write it down, it didn’t happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don’t tell you how. Based on industry best practices, this course clarifies ...
The Center for Professional Innovation and Education

Process Validation for Medical Devices

The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation. Internationally, regulators believe through careful design and validation of the process and appropriate process controls, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon ...
The Center for Professional Innovation and Education

ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development

The content of this overview course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines. The various types of ADME, PK/TK, and DM studies, which include in vitro metabolism and delivery, animal and human pharmacokinetics, protein binding, mass balance, tissue distribution, metabolite isolati...
The Center for Professional Innovation and Education

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