Click Here To Download The Brochure
Join Top Drug Development Course To Shape Your Career!
The most successful among all courses for drug development, this course a World Compliance Seminars covers the most productive areas. It considers the worldwide market for the pharmaceutical industry along with other significant therapeutic areas. It also takes care of the professionals involved in the pharmaceutical industry. The course includes a wide spectrum of things and objectives that are necessary for everyone who enrolls for the best Drug Development Course. It includes the identification of drug targets and preparation of chemicals used in the making of drugs of various types. Furthermore, the experts take care of the developments in biologics, toxicity examination, clinic tests and examination, pre-clinical development, pharmacokinetics, and also pharmacovigilance. The process, thus, takes care of everything from the discovery of the drugs to post-marketing strategies. The developers involved in the process then explain all necessary aspects of the process of drug development.
2 Day Agenda
Presenting the Overview Of Drug Development Products
- Explanation of product types and directions of administration
- The comprehensive process of drug development
- Definition and remedies involved in drug development
View on the global pharmaceutical and drug market
- Global market shares of biological and chemical drugs
- Role and responsibilities of professionals in drug development
- Size and key therapeutic areas
- Area-wise alterations
Drug discovery
- Targets of the Drug in development
- The Anthropological Genome Project
- Lead compound recognition and optimization
Break
Supervisory submissions
- Preparation of Common Technical Document
- CTD components
- Provincial managerial material
- The application procedure for biologic and chemical drug products – US and EU
Break
Pre-clinical development
- In-procedure controls and issue testing
- Solubility, penetrability, and verbal bioavailability
- Preparation decisions for refining bioavailability
- Visual isomerism
- Polymorph and salt form screening
- Common formulation types
Clinical Research
- Serious excellence qualities
- Clinical education design
- Methodical Increase Facts
- Adversative incident reporting
- Influence of mobile calculation on scientific investigate
Pharmacokinetics and toxicity Checks
- Drug plasma absorption shapes
- Preoccupation, delivery, absorption, and the abolition of drugs
- First-pass absorption
- Types of toxicity screening
Break 15 mins
Post-endorsement alteration
- Difficulties regarding creation development
- New ICH Q12 – the promise of relaxed post-sanction change
- The present or existing situation
US and EU Pharmacovigilance Significant fundamentals of rule
- Drug product creation
- Delivery
- ICH direction
Who will Benefit:
- Medical and clinical investigators
- Investigation & expansion scientists
- Quality Assurance professionals
- Scientific Research professionals
- Auditors
- Strategic planners
- Senior sales managers
- Regulatory Affairs Professionals
- Non-scientific employees of pharmaceutical companies who would like to understand how drugs are developed
- Regulatory affairs professionals
- Project managers
- CMC/pharmaceutical research professionals
- Manufacturing Personnel
- Newly-appointed staff with no previous experience in the pharmaceutical industry
- Financial managers
- Brand team personnel
- Statisticians & data management professionals
- A pharmaceutical employee who wishes to better their knowledge of drug development
Objectives of Learning:
Every participant in Drug Development Course can learn the following by the end of this course:
- The construction of controlling submissions
- How drugs are partitioned for noxiousness
- Parts of dissimilar medicinal specialists
- Issues moving oral bioavailability
- Archetypal costs and timelines related to drug development.
- The evidence obtained at each stage of scientific research.
- How the safety and effectiveness of drug products are protected during QC announcement testing
- How new drugs are developed against targets in the human body.
- The potential influence of polymorphism, salt form, and isomerism on efficacy and safety
- Details because drugs fail throughout the growth procedure
- How formulation can affect drug performance
-
How the manufacture and distribution of drugs are measured
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.
8.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 8 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
