worldcomplianceseminars.com Open in urlscan Pro
2606:4700::6813:ee75  Public Scan

Form analysis
1 forms found in the DOM

GET /purchase

<form class="block__pricing flex-grow" action="/purchase" method="get">
  <input type="hidden" name="course_id" value="1117375" id="course_id">
  <div class="block__pricing__heading empty_state__heading-text b-92110395-heading_text_color rich-text">
    <h4 class="ql-align-center"><strong>Choose a Purchase Options</strong></h4>
    <p><br></p>
  </div>
  <div class="block__pricing__plans">
    <section class="block__pricing__plan" data-id="3862761">
      <div class="block__pricing__plan__radio-wrapper">
        <input checked="" class="radio block__pricing__plan__radio" name="product_id" type="radio" value="3862761">
        <div class="block__pricing__plan__radio__custom-indicator"></div>
      </div>
      <div class="block__pricing__plan__text">
        <div class="block__pricing__plan__price" data-include-vat-price="3862761">$1,194</div>
        <h3 class="block__pricing__plan__name">One Dial-in One Attendee - Live</h3>
        <h4 class="block__pricing__plan__subtitle">
        </h4>
        <div class="block__pricing__plan__description__container" data-collapsed="false">
          <button class="block__pricing__plan__description__show-button expanded auto_expanded" type="button">
            <span class="block__pricing__plan__description__show-button__text">Less</span>
            <span class="block__pricing__plan__description__show-button__icon"></span>
          </button>
          <div class="block__pricing__plan__description" aria-hidden="false">
            <p>You'll have access to single log-in of the entire 2 day virtual seminar live including the Q&amp;A period, for single participant. You'll also receive all presentation materials.</p>
          </div>
        </div>
      </div>
    </section>
    <section class="block__pricing__plan" data-id="3862762">
      <div class="block__pricing__plan__radio-wrapper">
        <input class="radio block__pricing__plan__radio" name="product_id" type="radio" value="3862762">
        <div class="block__pricing__plan__radio__custom-indicator"></div>
      </div>
      <div class="block__pricing__plan__text">
        <div class="block__pricing__plan__price" data-include-vat-price="3862762">$1,183.20</div>
        <h3 class="block__pricing__plan__name">Recorded On Demand One Attendee</h3>
        <h4 class="block__pricing__plan__subtitle">
        </h4>
        <div class="block__pricing__plan__description__container" data-collapsed="true">
          <button class="block__pricing__plan__description__show-button" type="button">
            <span class="block__pricing__plan__description__show-button__text">More</span>
            <span class="block__pricing__plan__description__show-button__icon"></span>
          </button>
          <div class="block__pricing__plan__description hidden">
            <p>2 Day Virtual Seminar . You get one log-in for the On Demand Recorded Access for 2 day virtual seminar for one participant includes presentation materials , Certificate and the opportunity to ask questions by phone and email. Access
              valid for 12 months.</p>
            <p><br></p>
            <p><br></p>
            <p>$2,995</p>
            <p>Group-Max. 5 Attendees - Live</p>
            <p>More&nbsp;</p>
            <p><br></p>
            <p>$2,998</p>
            <p>Group 5 user On Demand</p>
            <p>More&nbsp;</p>
          </div>
        </div>
      </div>
    </section>
    <section class="block__pricing__plan" data-id="3862765">
      <div class="block__pricing__plan__radio-wrapper">
        <input class="radio block__pricing__plan__radio" name="product_id" type="radio" value="3862765">
        <div class="block__pricing__plan__radio__custom-indicator"></div>
      </div>
      <div class="block__pricing__plan__text">
        <div class="block__pricing__plan__price" data-include-vat-price="3862765">$3,594</div>
        <h3 class="block__pricing__plan__name">Group-Max. 5 Attendees - Live</h3>
        <h4 class="block__pricing__plan__subtitle">
        </h4>
        <div class="block__pricing__plan__description__container" data-collapsed="true">
          <button class="block__pricing__plan__description__show-button" type="button">
            <span class="block__pricing__plan__description__show-button__text">More</span>
            <span class="block__pricing__plan__description__show-button__icon"></span>
          </button>
          <div class="block__pricing__plan__description hidden">
            <p>You get Group log-in for the live virtual seminar for 5 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email.</p>
          </div>
        </div>
      </div>
    </section>
    <section class="block__pricing__plan" data-id="3862766">
      <div class="block__pricing__plan__radio-wrapper">
        <input class="radio block__pricing__plan__radio" name="product_id" type="radio" value="3862766">
        <div class="block__pricing__plan__radio__custom-indicator"></div>
      </div>
      <div class="block__pricing__plan__text">
        <div class="block__pricing__plan__price" data-include-vat-price="3862766">$3,597.60</div>
        <h3 class="block__pricing__plan__name">Group 5 user On Demand</h3>
        <h4 class="block__pricing__plan__subtitle">
        </h4>
        <div class="block__pricing__plan__description__container" data-collapsed="true">
          <button class="block__pricing__plan__description__show-button" type="button">
            <span class="block__pricing__plan__description__show-button__text">More</span>
            <span class="block__pricing__plan__description__show-button__icon"></span>
          </button>
          <div class="block__pricing__plan__description hidden">
            <p>You get Group log-in for the On Demand Recorded Access for 2 day virtual seminar for one participant includes presentation materials , Certificate and the opportunity to ask questions by phone and email. Access valid for 12 months.</p>
          </div>
        </div>
      </div>
    </section>
  </div>
  <div class="block__pricing__button-wrapper">
    <button class="block__pricing__button b-92110395-button_border_radius base-button" type="submit">Register Now</button>
  </div>
</form>

Text Content

Follow us:


 * Live Webinars
 * OnDemand
 * USA Seminars
 * Europe Seminars
 * Toll Free 844-267-7299
   
 * More
   * Seminars
   * Pharmaceutical Training
   * About Us
   * GLP Training
 * Login
 * Sign Up


DRUG DEVELOPMENT: KEY TO SUCCESS FROM CONCEPT TO COMMERCIALIZATION COURSE

2-DAY VIRTUAL SEMINAR

MAY 12-13 , 2022 AT 12:30 PM – 05:00 PM EDT | 09:30 AM – 02:00 PM PDT

Both Live and On Demand Recorded Options Available

Purchase Options


LEARN DRUG DEVELOPMENT PROCESS TRAINING COURSE

The course begins by considering the global pharmaceutical market, important
therapeutic areas and the roles of different Pharmaceutical professionals in the
development process, as well as a definition of drugs and medical devices.
Course include the identification of drug targets, synthesis of chemical drugs
and the development of biologics, pharmacokinetics and toxicity screening,
pre-clinical development, clinical studies, regulatory submissions, managing
post-approval change, pharmacovigilance and an overview of regulations governing
drug manufacture and distribution. The drug development process, from discovery
to post-marketing surveillance, is then explained. This course is designed to
teach employees of pharmaceutical companies who would like an understanding of
the drug development and regulatory approval process.


2 DAY AGENDA

Drug Development Products Overview

 * Product types and routes of administration
 * The drug development process
 * Risks in drug development

The International pharmaceutical market

 * Market shares of chemical and biological drugs
 * Roles of drug development professionals
 * Size and key therapeutic areas
 * Regional differences

Drug discovery

 * Drug targets
 * The Human Genome Project
 * Lead compound identification and optimisation

Break

Regulatory submissions

 * The Common Technical Document
 * CTD modules
 * Regional administrative information
 * The application process for chemical and biologic drug products – US and EU

Break

Pre-clinical development

 * Optical isomerism
 * Formulation options for improving bioavailability
 * Common formulation types
 * Critical quality attributes
 * In-process controls and release testing
 * Polymorph and salt form screening
 * Solubility, permeability and oral bioavailability

Clinical research

 * Clinical study design
 * Clinical development Phases
 * Establishing safety and efficacy/ bio equivalence
 * Adverse event reporting
 * Impact of mobile computing on clinical research

Pharmacokinetics and toxicity

 * Drug plasma concentration profiles
 * Absorption, distribution, metabolism and elimination of drugs
 * First-pass metabolism
 * Types of toxicity screening

Break 15 mins

Post-approval change

 * Problems concerning product improvement
 * New ICH Q12 – the promise of easier post-approval change
 * Current situation

US and EU Pharmacovigilance Important elements of regulation

 * Drug product manufacture
 * Distribution
 * ICH guidance

Final questions, feedback and close


WHO WILL BENEFIT:

 * Non-scientific employees of pharmaceutical companies who would like to
   understand how drugs are developed (e.g. IT, human resources, engineering and
   administrative staff)
 * Recently-appointed scientific staff with no previous experience of the
   pharmaceutical industry
 * Research & development scientists
 * Clinical Research Associates
 * Auditors
 * Regulatory Affairs Professionals
 * CMC/pharmaceutical research professionals
 * Regulatory affairs professionals
 * Project managers
 * Financial managers
 * Brand team personnel
 * Senior sales managers
 * Strategic planners
 * Quality Assurance Personnel
 * Manufacturing Personnel
 * Medical and clinical investigators 
 * Statisticians & data management professionals
 * Any pharmaceutical employee wishing to improve their knowledge of drug
   development


LEARNING OBJECTIVES:

By the end of this course, you will understand:

 * Roles of different pharmaceutical professionals
 * Typical costs and timelines associated with drug development
 * How new drugs are developed against targets in the human body
 * The structure of regulatory submissions
 * Reasons why drugs fail during development process
 * Factors affecting oral bioavailability
 * The size of the global pharmaceutical market and the key therapeutic areas
   being addressed by innovator companies
 * How drugs are screened for toxicity
 * The potential influence of polymorphism, salt form and isomerism on efficacy
   and safety
 * How formulation can affect drug performance
 * How the safety and efficacy of drug products are ensured during QC release
   testing
 * The information obtained at each stage of clinical research
 * How post-approval changes to drug products are managed
 * How the manufacture and distribution of marketed drug products are controlled

FACULTY KARL M. NOBERT (25+ YRS EXP)

Senior Counsel Michael Best & Friedrich LLP - USA

Karl focuses his practice in FDA Regulatory law, representing U.S. and
international clients in the food and drug industries with regard to
pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages
including dairy products, cosmetics, vitamins and dietary supplements, and
veterinary products.

He has particular experience in the areas of prescription drugs and regenerative
medicine, and has counseled numerous clients seeking FDA approval for Rx drugs
and cellular-based products to treat both humans and animals.



CHOOSE A PURCHASE OPTIONS




$1,194


ONE DIAL-IN ONE ATTENDEE - LIVE



Less

You'll have access to single log-in of the entire 2 day virtual seminar live
including the Q&A period, for single participant. You'll also receive all
presentation materials.

$1,183.20


RECORDED ON DEMAND ONE ATTENDEE



More

2 Day Virtual Seminar . You get one log-in for the On Demand Recorded Access for
2 day virtual seminar for one participant includes presentation materials ,
Certificate and the opportunity to ask questions by phone and email. Access
valid for 12 months.







$2,995

Group-Max. 5 Attendees - Live

More 




$2,998

Group 5 user On Demand

More 

$3,594


GROUP-MAX. 5 ATTENDEES - LIVE



More

You get Group log-in for the live virtual seminar for 5 participants,
presentation materials , Certificate and the opportunity to ask questions by
phone and email.

$3,597.60


GROUP 5 USER ON DEMAND



More

You get Group log-in for the On Demand Recorded Access for 2 day virtual seminar
for one participant includes presentation materials , Certificate and the
opportunity to ask questions by phone and email. Access valid for 12 months.

Register Now


OUR PAST SEMINAR TESTIMONIAL




The presentation by Carolyn Troiana today was fantastic, both I and the QA
Manager (Aaron Neighbour) loved it and had extensive conversation afterward
about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain
the perspective of somebody that has implemented these regulations in a working
lab. Virtual Seminar on ( Training on Life cycle Management of Analytical
Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity
and what the FDA is looking for per the regulations. ( Current Regulatory
Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information
to be shared in detail. (Training Attended on Risk Based Verification and
Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

TOP FDA FEATURED COURSE





ADVANCED PHARMACOVIGILANCE AUDITING AND INSPECTIONS VIRTUAL LIVE TRAINING COURSE



JULY 20-21 PHARMACOVIGILANCE AUDITING INSPECTION COURSE WILL EXPLAIN HOW TO
PREPARE FOR THE AUDIT INSPECTION, OVERVIEW OF THE EUROPEAN MEDICINES AGENCY'S
GUID

Michael Ramcharan

% COMPLETE

$2,274


RISK MANAGEMENT OF RAW MATERIALS IN A GMP ENVIRONMENT



JUNE 02 | AUG 09 THE LIVE TRAINING WEBINAR WILL EXPLORE THE NUMBER OF LOTS
REQUIRED TO BE TESTED BEFORE REDUCED TESTING MIGHT OCCUR

Barry A. Friedman

% COMPLETE

$462


FDA COMPLIANCE AND MOBILE APPLICATIONS BEST PRACTICES FOR ENSURING COMPLIANCE



APR 20 YOU SHOULD ATTEND THIS WEBINAR IF YOU ARE RESPONSIBLE FOR PLANNING,
EXECUTING OR MANAGING THE IMPLEMENTATION OF ANY SYSTEM GOVERNED

Carolyn Troiano

% COMPLETE

$298.80

View All Products


ABOUT WORLD COMPLIANCE SEMINARS (WCS)

World Compliance Seminars (WCS) is one stop solution for all
your pharmaceutical, biotechnology and medical device certification program
needs. The pharmaceutical and medical device training requirements are set forth
by the FDA (Food and Drug Administration) and other major regulatory bodies
like NIH, EMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are
responsible for the education, professional development, and on-the-job
training. The training is broken down into different sections to cover a wide
variety of topics, including pharmaceutical formulation, pharmaceutical transfer
processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory
Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and
many more.

The pharmaceutical and medical device requirements that the FDA has set forth
are designed to protect the public's health and safety. Pharmaceutical reps must
adhere to all of the regulations and education courses provided by the FDA in
order to be considered one of the best in their field. They also must complete
ongoing educational opportunities and maintenance programs in order to maintain
relevance and career enhancement.

Learn More

 * © WCS 2022
 * About Us
 * Contact Us
 * USA FDA Seminars
 * Europe Seminars
 * Pharmaceutical Training
 * Sitemap
 * GLP Training

 * Terms of Use
 * Privacy Policy

Completed Incomplete Incomplete disabled
Share
Tweet
Pin
Email
Share
Share
Share
Print



Powered byPicreel