Johnson & Johnson's licence for cosmetics cancelled

The Food and Drug Administration (FDA) recently cancelled Johnson & Johnson India’s license to produce cosmetic products at their Mulund plant. FDA’s order will come into effect from June 24.

According to FDA officials, the order was issued in a case dating back to 2007 when they found that 15 batches of Johnson & Johnson baby powder were sterilized by ethylene oxide, a known carcinogenic and irritant.

 “While Ethylene Oxide can be used for sterilisation, the company did not bother to carry out a test after the process to check the amount of residue in the product,” said FDA joint commissioner KB Shende, adding that the company can appeal to the state government before the order comes into effect.

  “The products are used for new born babies. IT IS MUST for the company to follow all measures,” said Shende adding that the traces of ethylene oxide, if any, should have been measured. The 15 batches in question consisted of 160,000 containers.

Clinical Research News

Promising Phase I Clinical Trial of Rogosertib Leads To Multi-Institutional Phase II Trial

Results of a phase 1 clinical trial reported at the American Association for Cancer Research (AACR) annual conference show that orally administered Rigosertib is well tolerated in patients with advanced solid tumors. This is the first trial in which orally administered Rigosertib, a dual kinase inhibitor, was studied in solid tumors. Intravenously rigosertib is already in phase 3 clinical trials for myelodysplastic syndrome and pancreatic cancer and oral rigosertib is being studied in a pair of Phase II trials in lower-risk transfusion dependent MDS patients. The drug candidate is being developed by Onconova Therapeutics, Inc., of Pennington, NJ. 

Three top students of November batch

          Three top students of November batch

     

          •Dr Neethu,

          •MMSH,Medical Writing

    

        •Dr Savitha

        •Synowledge, Drug safety associate 

    

      •Dr Nihar

           • Indegene,Clinical Trial Analyst

How does it feel when a most desirable position in the CR world- medical writing in this case, comes as a windfall, you may want to ask Ms Madhurya  on how they feels on being on cloud nine who got selected with MNC at an attractive pay package. - Congratulations Madhurya. Avigna Clinical Research Institute review

WORKSHOP ON PHARMACOVIGILENCE AT COIMBATORE

• Learnt about the current scenario of India Pharmaceutical Market.
• Gained depth knowledge of Pharmacovigilence and its process.
• Learnt about the current Guidelines applied for periodic safety update reports.
• Learnt about the transfer of adverse event information from vigiflow to vigibase.
• Ethics committee and its quality in India.

Pictures of Workshop

 Students and staff of ACRI @ Workshop

Students and Staff of ACRI attended a workshop on dia

4th Pharmacovigilence conference took place in Bangalore from 8th to 9th March 2013.  It was held in the Vivanta by Taj – Yeshwantpur Bangalore. 

Inauguration and opening remark was by:         

   Dr Moin Don  - Director and Founder of PVCON, PV Consulting Services.

   Dr Vivek Ahuja - Director, Pharmacovigilance Asia Pacific, Baxter Healthcare.                                             

Avigna Clinical Research Institute: Review

Joining an MNC is every young graduates dream and two of our candidates, Mr Venu Madhav got selected for a leading American Healthcare company with an attractive salary.

Medical Coding and Coding Process

Coding is the translation of medical information relating to a patient's encounter with a health care provider into alphanumeric code.

Coding plays a very important role in establishing and converting the clinical and medical information into a code which helps us to save time and space.

Different Types of Coding System are:-

1. MedDRA-Medical Dictionary for regulatory activities.
2. WHODRL- WHO Drug Reference List .
3. COSTART- Coding Symbols for the Thesaurus of Adverse Reaction Terminology.
4. WHO-ART- WHO Adverse Reaction Terminology.
5. HARTS- Hoechst Adverse Reaction Terminology System.
6. ICD- International Classification of Diseases.
7. ICD-9-CM International Classification of Diseases, 9th Revision, Clinical Modification.

The Medical Dictionary for Regulatory Activities (MedDRA) Terminology is the international medical terminology developed under the sponsorship of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.

The MedDRA terminology applies to all phases of drug development, excluding animal toxicology.  It also applies to the health effects and malfunction of devices. 

The Categories of terms Classified as medical for these purposes are as follows:

• Signs.

• Symptoms.

• Diseases.

• Diagnoses.

• Therapeutic Indications.

• Names and Qualitative Results of Investigations.

• Surgical and Medical Procedures.

• Medical / Social/ Family History.

The five-level structure of this terminology provides options for retrieving data by specific or broad groupings, according to the level of specificity required.

Structural Elements of the Terminology

Coding Process:   

1.   Auto coding:-The term recorded by investigator gets coded automatically.

2.   Manual Coding:-When autocoder fails to code the term. All terms has to be coded manually.

Computer supported step

Uses Autocoders to try and match at least some codes automatically :

1.   Autocoder provides minimal support and company does not update dictionary tables when making a manual assignment. 

2.   Autocoder makes all the updates to the data record and the company updates dictionary tables when making a new assignment of a code to a term.

Coding Process Steps:

A .Coding process with minimal Autocoder support:

• Collect and store the reported term.
• Run Autocoder.
• If a code is found, Autocoder stores the result.
• If a code is not found, Autocoder flags the term for manual coding.
• Manual review of uncoded terms either assigns a code by updating the record.
• Registers a discrepancy on the reported terms.

B. Coding process with heavy reliance on Autocoder:

• Collect and store the reported term.
• Run Autocoder.
• If a code is found, Autocoder stores the result.
• If a code is not found, Autocoder stores the term for manual coding.
• Manual review of uncoded terms assigns a code in a separate table.
• Registers a discrepancy on the reported term.
• Rerunning the Autocoder, then finds a match.

   Advantages

• Saves Time.
• Saves Money.
• Fastens the approval process. 
• Standardize the reported term.
• Multilingual Terminology. 
• Facilitates communication between Industry and Regulators.

Challenges:-

• Illegible verbatim.
• Spelling errors. 
• Use of abbreviation. 
• Multiple medications recorded. 
• Non-contributing words which would require common text transformation.

The More Common text Transformations are:

• Capitalization.
• Removal of selected punctuation, symbols, and extra spaces.
• Removal of numbers and numeric words.
• Removal of dates and date words.
• Removal of noncontributing words.
• Replacement of words with standard terms.
• Alphabetizing the phrase.

Reference:

MedDRA Introductory Guide.